Trial Outcomes & Findings for Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients (NCT NCT02546856)
NCT ID: NCT02546856
Last Updated: 2020-12-16
Results Overview
BB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
320 participants
Primary outcome timeframe
4 months
Results posted on
2020-12-16
Participant Flow
Participant milestones
| Measure |
Heart Failure (HF) Nurse Up-titration
Intervention:The cardiologist prescribes drugs and the HF-nurse implements the up-titration, driven by protocol based on 2012 ESC HF guidelines, with cardiologist support.
Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure "De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients
|
Heart Failure (HF) Cardiologist Up-titration
Active Comparator:The cardiologist prescribes and decides dosage following a protocol based on 2012 ESC HF guidelines, with nursing clinical and educational support.
Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure "De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients
|
|---|---|---|
|
4 Months Evaluation
STARTED
|
164
|
156
|
|
4 Months Evaluation
COMPLETED
|
144
|
145
|
|
4 Months Evaluation
NOT COMPLETED
|
20
|
11
|
|
6 Months Evaluation
STARTED
|
144
|
145
|
|
6 Months Evaluation
COMPLETED
|
136
|
138
|
|
6 Months Evaluation
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Heart Failure (HF) Nurse Up-titration
Intervention:The cardiologist prescribes drugs and the HF-nurse implements the up-titration, driven by protocol based on 2012 ESC HF guidelines, with cardiologist support.
Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure "De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients
|
Heart Failure (HF) Cardiologist Up-titration
Active Comparator:The cardiologist prescribes and decides dosage following a protocol based on 2012 ESC HF guidelines, with nursing clinical and educational support.
Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs of Heart Failure "De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients
|
|---|---|---|
|
4 Months Evaluation
Death
|
2
|
3
|
|
4 Months Evaluation
Withdrawal by Subject
|
2
|
3
|
|
4 Months Evaluation
Lost to Follow-up
|
3
|
3
|
|
4 Months Evaluation
Physician Decision
|
3
|
0
|
|
4 Months Evaluation
Working or living abroad
|
5
|
1
|
|
4 Months Evaluation
reasons not due to titration
|
4
|
1
|
|
4 Months Evaluation
HF Unit not active in summer
|
1
|
0
|
|
6 Months Evaluation
Death
|
1
|
1
|
|
6 Months Evaluation
Lost to Follow-up
|
1
|
1
|
|
6 Months Evaluation
Working or living abroad
|
6
|
4
|
|
6 Months Evaluation
reasons not due to titration
|
0
|
1
|
Baseline Characteristics
n considered for baseline doses In both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month. We evaluated the 4 month titration process made by HF cardiologist vs HF nurse. Patients who left the study did not receive this intervention.
Baseline characteristics by cohort
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=156 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=164 Participants
Patients, following a protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular Ejection Fraction ≤ 40% Patients, . Protocol based on 2012 ESC HF guidelines.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.64 years
STANDARD_DEVIATION 12.25 • n=156 Participants
|
61.88 years
STANDARD_DEVIATION 12.14 • n=164 Participants
|
61.28 years
STANDARD_DEVIATION 12.19 • n=320 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=156 Participants
|
45 Participants
n=164 Participants
|
83 Participants
n=320 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=156 Participants
|
119 Participants
n=164 Participants
|
237 Participants
n=320 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=156 Participants
|
164 Participants
n=164 Participants
|
320 Participants
n=320 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Region of Enrollment
Spain
|
156 participants
n=156 Participants
|
164 participants
n=164 Participants
|
320 participants
n=320 Participants
|
|
betablocker mean relative dose
|
34.80 % to target dose
STANDARD_DEVIATION 20.6 • n=145 Participants • n considered for baseline doses In both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month. We evaluated the 4 month titration process made by HF cardiologist vs HF nurse. Patients who left the study did not receive this intervention.
|
34.81 % to target dose
STANDARD_DEVIATION 18.16 • n=144 Participants • n considered for baseline doses In both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month. We evaluated the 4 month titration process made by HF cardiologist vs HF nurse. Patients who left the study did not receive this intervention.
|
34.80 % to target dose
STANDARD_DEVIATION 19.38 • n=289 Participants • n considered for baseline doses In both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month. We evaluated the 4 month titration process made by HF cardiologist vs HF nurse. Patients who left the study did not receive this intervention.
|
|
left ventricular ejection fraction %
|
27.45 %of blood leaving the heart /beat
STANDARD_DEVIATION 7.25 • n=156 Participants
|
27.95 %of blood leaving the heart /beat
STANDARD_DEVIATION 6.69 • n=164 Participants
|
27.71 %of blood leaving the heart /beat
STANDARD_DEVIATION 6.97 • n=320 Participants
|
|
Nt-proBNP
|
3001 pg/ml
STANDARD_DEVIATION 4041 • n=139 Participants • other patients had BNP
|
3425 pg/ml
STANDARD_DEVIATION 5256 • n=145 Participants • other patients had BNP
|
3217 pg/ml
STANDARD_DEVIATION 4697 • n=284 Participants • other patients had BNP
|
|
6 minute walking test
|
370 meters
STANDARD_DEVIATION 108 • n=156 Participants
|
361 meters
STANDARD_DEVIATION 102 • n=164 Participants
|
366 meters
STANDARD_DEVIATION 105 • n=320 Participants
|
|
Number of participants with New York Heart Association (NYHA) I,II,III,IV
NYHA I
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Number of participants with New York Heart Association (NYHA) I,II,III,IV
NYHA II
|
128 Participants
n=156 Participants
|
139 Participants
n=164 Participants
|
267 Participants
n=320 Participants
|
|
Number of participants with New York Heart Association (NYHA) I,II,III,IV
NYHA III
|
28 Participants
n=156 Participants
|
25 Participants
n=164 Participants
|
53 Participants
n=320 Participants
|
|
Number of participants with New York Heart Association (NYHA) I,II,III,IV
NYHA IV
|
0 Participants
n=156 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=320 Participants
|
|
Minnesota living with heart failure questionnaire
|
45.71 units on a scale
STANDARD_DEVIATION 22.21 • n=156 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 22.61 • n=164 Participants
|
48.31 units on a scale
STANDARD_DEVIATION 22.52 • n=320 Participants
|
|
European Quality of Life Scale: EuroQol- 5 Dimension index
|
0.75 score on a scale
STANDARD_DEVIATION 0.24 • n=156 Participants
|
0.73 score on a scale
STANDARD_DEVIATION 0.23 • n=164 Participants
|
0.74 score on a scale
STANDARD_DEVIATION 0.23 • n=320 Participants
|
|
ACEI mean relative dose
|
40.13 % to target dose
STANDARD_DEVIATION 25.38 • n=121 Participants • n considered to calculate the mean baseline doses of ACEI in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ACEI. Alternatively It was possible to be prescribed ARB/sacubitril-valsartan or nothing
|
45.92 % to target dose
STANDARD_DEVIATION 30.06 • n=118 Participants • n considered to calculate the mean baseline doses of ACEI in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ACEI. Alternatively It was possible to be prescribed ARB/sacubitril-valsartan or nothing
|
43.04 % to target dose
STANDARD_DEVIATION 27.81 • n=239 Participants • n considered to calculate the mean baseline doses of ACEI in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ACEI. Alternatively It was possible to be prescribed ARB/sacubitril-valsartan or nothing
|
|
Angiotensin II Receptor Blockers (ARB) mean relative dose
|
43.20 % to target dose
STANDARD_DEVIATION 20.63 • n=8 Participants • n considered to calculate the mean baseline doses of ARA in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ARB. Alternatively It was possible to be prescribed ACEI/sacubitril-valsartan or nothing
|
29.15 % to target dose
STANDARD_DEVIATION 14.99 • n=16 Participants • n considered to calculate the mean baseline doses of ARA in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ARB. Alternatively It was possible to be prescribed ACEI/sacubitril-valsartan or nothing
|
33.84 % to target dose
STANDARD_DEVIATION 17.95 • n=24 Participants • n considered to calculate the mean baseline doses of ARA in both groups: only the patients who received a prescription at baseline were included in the analysis. Every patient was prescribed betablocker but not ARB. Alternatively It was possible to be prescribed ACEI/sacubitril-valsartan or nothing
|
|
MRA mean relative dose
|
63.18 % to target dose
STANDARD_DEVIATION 33.00 • n=127 Participants • n for MRA baseline doses in both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month and had a prescription during the titration period at any time. Every patient was prescribed betablocker but not MRA. It was possible not having the need of its prescription.
|
61.4 % to target dose
STANDARD_DEVIATION 33.52 • n=125 Participants • n for MRA baseline doses in both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month and had a prescription during the titration period at any time. Every patient was prescribed betablocker but not MRA. It was possible not having the need of its prescription.
|
62.30 % to target dose
STANDARD_DEVIATION 33.21 • n=252 Participants • n for MRA baseline doses in both groups: patients, who were at the time of measuring the achieved doses after titration, the 4th month and had a prescription during the titration period at any time. Every patient was prescribed betablocker but not MRA. It was possible not having the need of its prescription.
|
PRIMARY outcome
Timeframe: 4 monthsBB mean Relative dose is the mean dose of betablockers achieved 4 months after starting titration, relative to target dose ( %) , which is the target dose of european heart failure guidelines for BB.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
BB % Relative Dose (Mean) With Regard to Target Dose
|
56.29 percentage of target dose
Standard Deviation 31.3
|
71.09 percentage of target dose
Standard Deviation 31.05
|
SECONDARY outcome
Timeframe: 4 monthsNumber of participants with worsening renal function during the titration process (from baseline to 4 month) that could be associated to the titration process (Creatinine increase \>50% baseline creatinine or creatinine\>3mg/dl, or Estimated Glomerular Filtration\<25 ml/min/1.73 m2)
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Participants With Worsening Renal Function (From Baseline to 4th Month)
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 monthsNumber of participants with Potassium≥ 5.5 meq/l during the titration process (from baseline to 4 month) that could be associated to this titration process
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month)
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 monthsDescription: Number of participants with symptomatic hypotension during the titration process (from baseline to 4 month) that could be associated to this titration process. Symptomatic hypotension defined as symptoms such as dizziness or light headedness, associated to hypotension
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month)
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 4 monthsNumber of participants with Heart Rate (HR) \< 50 beats per minute during the titration process (from baseline to 4 month) , which could be associated to the titration process. (with or without symptoms)
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month)
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 4 monthsNumber of patients with AV Block during the titration process, associated to the BB titration
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Patients With Atrio Ventricular (AV) Block Due to Titration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsNumber of patients with worsening of heart failure signs and symptoms during the titration process ( from baseline to 4 month) which could be associated to the titration process.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Patients With Worsening of Heart Failure Signs and Symptoms
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 monthsNumber of patients with admissions due to titration ( not due to other causes)
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Patients With Admissions Due to Titration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsNumber of patients: Mortality due to titration ( not due to other causes)
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Patients: Mortality Due to Titration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants analyzed are only participants with drug withdrawal
number of paticipants with drug Stop ( withdrawal) that occur during the titration process that could be due to an adverse event. ( it can be not only due to an adverse event but because there is no need of this drug or its substitution for another kind of drug)
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=12 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=9 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)
betablocker stop
|
3 Participants
|
1 Participants
|
|
Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)
ACEI stop
|
3 Participants
|
0 Participants
|
|
Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)
MRA stop
|
6 Participants
|
7 Participants
|
|
Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment)
ARB stop
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: It has to be taken into account that in outcome mesasures the order of groups and their number of participants is reversed ( first HF cardiologist, second HF nurse) in regard to those in the participant flow. ( first HF nurse, second HF cardiologist)
Change in % Left Ventricular Ejection Fraction (difference of change from baseline to 6 months between groups) Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=138 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=136 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Change in % Left Ventricular Ejection Fraction
|
15.46 percentage of blood expelled/each beat
Standard Deviation 11.46
|
15.63 percentage of blood expelled/each beat
Standard Deviation 13.29
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: BNP was analysed in 11 patients of both groups, instead of Nt proBNP ( 121/117).
Nt-proBNP (N-terminal pro-B type natriuretic peptide) Improvement (Decrease) difference of change from baseline to 6 months between groups, mean (SD)
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=121 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=117 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP)
|
-1577 pg/ml
Standard Deviation 3225
|
-1593 pg/ml
Standard Deviation 2733
|
SECONDARY outcome
Timeframe: 6 months6 minute walking test improvement ( change) meters.Improvement (difference of change from baseline to 6 months between groups Six minute walking test. Measurement of exercise capacity is an integral element in assessment of patients with cardiopulmonary disease. It provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions. The six-minute walk test (6MWT) measures the distance (meters) an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=138 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=136 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
6 Minute Walking Test
|
50.49 meters
Standard Deviation 74.20
|
57.76 meters
Standard Deviation 79.97
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants class I-IV New York Heart Association (NYHA) functional classification, based on severity of symptoms and physical activity: NYHA I (better): No limitation of physical activity; NYHA II: Slight limitation of ordinary physical activity, breathlessness; NYHA III: marked limitation of physical activity. Comfortable at rest, but less than ordinary activity results in undue breathlessness, fatigue or palpitations; NYHA IV ( worse): unable to carry on any physical activity without discomfort.Symptoms at rest can be present. If any physical activity is undertaken discomfort is increased.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=137 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=135 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV
NYHA II
|
86 Participants
|
72 Participants
|
|
Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV
NYHA IV
|
0 Participants
|
0 Participants
|
|
Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV
NYHA I
|
47 Participants
|
59 Participants
|
|
Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV
NYHA III
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsQuality of Life, measured by Minnesota Living with Heart Failure Questionnaire. Improvement (change) from baseline to 6 months. Minnesota Living With Heart Failure Questionnaire (MLWHFQ). The content of this questionnaire was selected to be representative of the ways heart failure and treatments can affect the key physical, emotional, social and mental dimensions of quality of life of patients with heart failure. It consist of 21-items with score 0-5. Final evaluation moves from 0 (none) to 105 (very much); a lower score means better quality of life.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=138 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=136 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Quality of Life: MLWHFQ
|
-25.01 score on a scale
Standard Deviation 23.22
|
-26.37 score on a scale
Standard Deviation 24.53
|
SECONDARY outcome
Timeframe: 6 monthsEuropean Quality of Life Scale: EuroQol- 5 Dimension index (Range: 1 full health-0 death). It measures health status self-reported by the patient. It has 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels: 1 no problem; 2 some or moderate problems; 3 extreme problems. The EuroQol Research Foundation converts this information into a single summary index, by applying a formula that attaches specific country values (called weights) to each of the levels in each dimension. The index is calculated by subtracting the mentioned weights from 1, the value for full health. We measured the EuroQol-5D index improvement (change) from baseline to 6 months. More information in: EQ-5D-3L-User-Guide\_version-6.0 (1).pdf
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=138 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=136 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
European Quality of Life Scale: EuroQol- 5 Dimension Index
|
0.04 score on a scale
Standard Deviation 0.28
|
0.08 score on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 6 monthsNumber of patients with hospital admissions due to Heart Failure. From Baseline to 6 months
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Patients With Admissions Due to Heart Failure (HF)
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of Patients with deaths due to Cardiovascular and non cardiovascular causes
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=4 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=3 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
Number of Patients With Deaths
mortality due to cardiovascular causes
|
2 Participants
|
2 Participants
|
|
Number of Patients With Deaths
mortality due to non cardiovascular causes
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 MonthsACEI mean Relative dose is the mean dose of ACEI achieved 4 months after starting titration, relative to target dose (%) described in European guidelines
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=115 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=115 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
ACEI % Relative Dose (Mean) With Regard to Target Dose
|
56.13 percentage of target dose
Standard Deviation 30.4
|
72.61 percentage of target dose
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: During the titration process several patients that at baseline did not have ARB prescription were prescribed this drug.
ARB, angiotensin II receptor blockers, mean relative dose ( % to target dose). Target dose is described in European guidelines. Measured at 4 months after starting titration.
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=20 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=18 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
ARB % Relative Dose (Mean) With Regard to Target Dose
|
43.51 percentage of target dose
Standard Deviation 33.7
|
44.48 percentage of target dose
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: 4 monthsMRA % relative dose (mean) is the mean dose achieved 4 months after starting titration with regard to target dose (%) described in european guidelines
Outcome measures
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=127 Participants
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" Left Ventricular ejection Fraction ≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=125 Participants
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" Left Ventricular ejection Fraction (EF) ≤ 40% Patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients. Protocol based on 2012 ESC HF guidelines.
|
|---|---|---|
|
MRA % Relative Dose (Mean) With Regard to Target Dose
|
70.47 percentage of target dose
Standard Deviation 29.8
|
71.00 percentage of target dose
Standard Deviation 32.1
|
Adverse Events
Heart Failure (HF) Cardiologist Up-titration
Serious events: 11 serious events
Other events: 20 other events
Deaths: 4 deaths
HF Nurse Up-titration
Serious events: 2 serious events
Other events: 22 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 participants at risk
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 participants at risk
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
|
|---|---|---|
|
Cardiac disorders
hospitalizations due to cardiovascular cause
|
7.6%
11/145 • Number of events 11 • From Baseline to 6 months
|
1.4%
2/144 • Number of events 2 • From Baseline to 6 months
|
Other adverse events
| Measure |
Heart Failure (HF) Cardiologist Up-titration
n=145 participants at risk
Active Comparator:Cardiologist decides dosage with nursing clinical and educational support.
HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines
|
HF Nurse Up-titration
n=144 participants at risk
Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration.
HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support
|
|---|---|---|
|
Cardiac disorders
heart rate <50 bpm
|
4.8%
7/145 • Number of events 7 • From Baseline to 6 months
|
6.9%
10/144 • Number of events 10 • From Baseline to 6 months
|
|
Cardiac disorders
symptomatic hypotension
|
9.0%
13/145 • Number of events 13 • From Baseline to 6 months
|
8.3%
12/144 • Number of events 12 • From Baseline to 6 months
|
Additional Information
Juana Oyanguren, Nursing graduate, Master in Heart Failure, CV Pathology and Thrombosis Specialist
Servicio de Cardiologıa, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain .BIOCRUCES, Instituto de Investigacion Sanitaria, Bizkaia, Spain
Phone: 34 656780945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place