Trial Outcomes & Findings for Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (NCT NCT01685840)
NCT ID: NCT01685840
Last Updated: 2017-12-12
Results Overview
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
894 participants
Primary outcome timeframe
24 Months
Results posted on
2017-12-12
Participant Flow
894 participants were randomized
Participant milestones
| Measure |
Usual Care
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Overall Study
STARTED
|
448
|
446
|
|
Overall Study
COMPLETED
|
119
|
114
|
|
Overall Study
NOT COMPLETED
|
329
|
332
|
Reasons for withdrawal
| Measure |
Usual Care
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Overall Study
Death
|
77
|
66
|
|
Overall Study
Lost to Follow-up
|
27
|
25
|
|
Overall Study
Physician Decision
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
14
|
17
|
|
Overall Study
Futility
|
197
|
200
|
|
Overall Study
Had VAD, Dialysis or Transplant
|
11
|
17
|
Baseline Characteristics
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
Baseline characteristics by cohort
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
Total
n=894 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
301 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
608 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
420 Participants
n=5 Participants
|
416 Participants
n=7 Participants
|
836 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
155 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
257 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
485 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsComposite of First Heart Failure Hospitalization or Cardiovascular Mortality
Outcome measures
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
CV Death or Heart Failure Hospitalization
|
164 events
|
164 events
|
SECONDARY outcome
Timeframe: 24 monthsAll-cause mortality by treatment arm
Outcome measures
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
All-cause Mortality
|
77 deaths
|
66 deaths
|
SECONDARY outcome
Timeframe: 24 monthsDays alive and not hospitalized for CV reasons
Outcome measures
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Cumulative Morbidity
|
616 days
Interval 595.0 to 637.0
|
626 days
Interval 605.0 to 646.0
|
SECONDARY outcome
Timeframe: 24 monthsCV death by treatment arm
Outcome measures
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
CV Death
|
57 deaths
|
53 deaths
|
SECONDARY outcome
Timeframe: 24 monthsFirst Heart Failure Hospitalization
Outcome measures
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Number of Hospitalizations for First Heart Failure
|
141 hospitalizations
|
147 hospitalizations
|
SECONDARY outcome
Timeframe: 24 monthsRecurrent Heart Failure Hospitalization
Outcome measures
| Measure |
Usual Care
n=448 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Number of Hospitalizations for Recurrent Heart Failure
|
277 hospitalizations
|
350 hospitalizations
|
SECONDARY outcome
Timeframe: Baseline, 3,6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.
Outcome measures
| Measure |
Usual Care
n=439 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=437 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Percentage of Patients With Moderate to Severe Depression
Baseline
|
34.6 percentage of participants
|
36.2 percentage of participants
|
|
Percentage of Patients With Moderate to Severe Depression
3 month
|
26.2 percentage of participants
|
27.8 percentage of participants
|
|
Percentage of Patients With Moderate to Severe Depression
6 month
|
25.6 percentage of participants
|
27.6 percentage of participants
|
|
Percentage of Patients With Moderate to Severe Depression
12 month
|
25.9 percentage of participants
|
27.6 percentage of participants
|
|
Percentage of Patients With Moderate to Severe Depression
24 month
|
25.4 percentage of participants
|
25.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Outcome measures
| Measure |
Usual Care
n=443 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=435 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Duke Activity Status Index (DASI)
Baseline
|
11.1 units on a scale
Standard Deviation 12.6
|
12.6 units on a scale
Standard Deviation 13.5
|
|
Duke Activity Status Index (DASI)
3 month
|
16.9 units on a scale
Standard Deviation 14.2
|
17.7 units on a scale
Standard Deviation 14.9
|
|
Duke Activity Status Index (DASI)
6 month
|
17.9 units on a scale
Standard Deviation 15.8
|
19.7 units on a scale
Standard Deviation 16.6
|
|
Duke Activity Status Index (DASI)
12 month
|
17.4 units on a scale
Standard Deviation 16.1
|
19.3 units on a scale
Standard Deviation 17.0
|
|
Duke Activity Status Index (DASI)
24 month
|
19.6 units on a scale
Standard Deviation 17.8
|
18.2 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
Outcome measures
| Measure |
Usual Care
n=439 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=431 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
EQ-5D Health Index
6 month
|
0.7 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.3
|
|
EQ-5D Health Index
12 month
|
0.7 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.3
|
|
EQ-5D Health Index
24 month
|
0.7 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.3
|
|
EQ-5D Health Index
Baseline
|
0.7 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.3
|
|
EQ-5D Health Index
3 month
|
0.7 units on a scale
Standard Deviation 0.3
|
0.7 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsThe EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Usual Care
n=446 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=445 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
EQ-5D Visual Analog Scale
Baseline
|
60.2 units on a scale
Standard Deviation 37.6
|
59.2 units on a scale
Standard Deviation 22.6
|
|
EQ-5D Visual Analog Scale
3 month
|
62.3 units on a scale
Standard Deviation 25.9
|
60.2 units on a scale
Standard Deviation 27.8
|
|
EQ-5D Visual Analog Scale
6 month
|
60.5 units on a scale
Standard Deviation 26.5
|
61.5 units on a scale
Standard Deviation 25.8
|
|
EQ-5D Visual Analog Scale
12 month
|
63.7 units on a scale
Standard Deviation 25.8
|
62.1 units on a scale
Standard Deviation 24.9
|
|
EQ-5D Visual Analog Scale
24 month
|
65.9 units on a scale
Standard Deviation 24.0
|
60.8 units on a scale
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: Baseline, 3, 6,12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
Usual Care
n=444 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=441 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
Baseline
|
57.7 units on a scale
Standard Deviation 22.4
|
57.5 units on a scale
Standard Deviation 21.6
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
3 month
|
69.2 units on a scale
Standard Deviation 22.8
|
68.8 units on a scale
Standard Deviation 22.6
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
6 month
|
70.1 units on a scale
Standard Deviation 22.2
|
70.4 units on a scale
Standard Deviation 21.8
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
12 month
|
70.3 units on a scale
Standard Deviation 21.9
|
68.4 units on a scale
Standard Deviation 24.3
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
24 month
|
71.6 units on a scale
Standard Deviation 24.4
|
70.2 units on a scale
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Outcome measures
| Measure |
Usual Care
n=441 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=436 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Short Form-36 (SF-36) General Health Subscale
Baseline
|
48.4 units on a scale
Standard Deviation 11.1
|
48.6 units on a scale
Standard Deviation 10.7
|
|
Short Form-36 (SF-36) General Health Subscale
3 month
|
51.1 units on a scale
Standard Deviation 12.6
|
50.0 units on a scale
Standard Deviation 12.9
|
|
Short Form-36 (SF-36) General Health Subscale
6 month
|
50.5 units on a scale
Standard Deviation 12.7
|
49.9 units on a scale
Standard Deviation 12.9
|
|
Short Form-36 (SF-36) General Health Subscale
12 month
|
51.0 units on a scale
Standard Deviation 12.2
|
50.8 units on a scale
Standard Deviation 12.6
|
|
Short Form-36 (SF-36) General Health Subscale
24 month
|
48.8 units on a scale
Standard Deviation 12.8
|
50.4 units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Outcome measures
| Measure |
Usual Care
n=441 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=438 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Short Form-36 (SF-36) Mental Health Subscale
24 month
|
79.6 units on a scale
Standard Deviation 17.6
|
76.6 units on a scale
Standard Deviation 22.1
|
|
Short Form-36 (SF-36) Mental Health Subscale
Baseline
|
69.7 units on a scale
Standard Deviation 20.4
|
69.8 units on a scale
Standard Deviation 20.9
|
|
Short Form-36 (SF-36) Mental Health Subscale
3 month
|
77.6 units on a scale
Standard Deviation 19.9
|
76.1 units on a scale
Standard Deviation 21.5
|
|
Short Form-36 (SF-36) Mental Health Subscale
6 month
|
77.7 units on a scale
Standard Deviation 20.5
|
77.1 units on a scale
Standard Deviation 21.3
|
|
Short Form-36 (SF-36) Mental Health Subscale
12 month
|
77.5 units on a scale
Standard Deviation 20.3
|
76.2 units on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Outcome measures
| Measure |
Usual Care
n=440 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=437 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Short Form-36 (SF-36) Social Functioning Subscale
Baseline
|
60.2 units on a scale
Standard Deviation 32.7
|
64.8 units on a scale
Standard Deviation 30.1
|
|
Short Form-36 (SF-36) Social Functioning Subscale
24 month
|
76.7 units on a scale
Standard Deviation 30.3
|
77.2 units on a scale
Standard Deviation 31.7
|
|
Short Form-36 (SF-36) Social Functioning Subscale
3 month
|
75.4 units on a scale
Standard Deviation 30.8
|
74.9 units on a scale
Standard Deviation 31.8
|
|
Short Form-36 (SF-36) Social Functioning Subscale
6 month
|
77.0 units on a scale
Standard Deviation 32.3
|
75.0 units on a scale
Standard Deviation 32.1
|
|
Short Form-36 (SF-36) Social Functioning Subscale
12 month
|
76.4 units on a scale
Standard Deviation 30.9
|
74.5 units on a scale
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Outcome measures
| Measure |
Usual Care
n=442 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=433 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Short Form-36 (SF-36) Physiological Functioning Subscale
Baseline
|
30.6 units on a scale
Standard Deviation 32.1
|
31.5 units on a scale
Standard Deviation 31.2
|
|
Short Form-36 (SF-36) Physiological Functioning Subscale
3 month
|
43.5 units on a scale
Standard Deviation 35.9
|
43.3 units on a scale
Standard Deviation 37.5
|
|
Short Form-36 (SF-36) Physiological Functioning Subscale
6 month
|
43.4 units on a scale
Standard Deviation 37.4
|
45.6 units on a scale
Standard Deviation 37.2
|
|
Short Form-36 (SF-36) Physiological Functioning Subscale
12 month
|
41.9 units on a scale
Standard Deviation 38.2
|
47.4 units on a scale
Standard Deviation 37.1
|
|
Short Form-36 (SF-36) Physiological Functioning Subscale
24 month
|
47.0 units on a scale
Standard Deviation 38.1
|
43.2 units on a scale
Standard Deviation 38.6
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 and 24 monthsPopulation: "Number of participants analyzed" is the number of participants who completed the questionnaire
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Outcome measures
| Measure |
Usual Care
n=441 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=438 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Short Form-36 (SF-36) Vitality Subscale
Baseline
|
43.9 units on a scale
Standard Deviation 22.5
|
44.3 units on a scale
Standard Deviation 22.3
|
|
Short Form-36 (SF-36) Vitality Subscale
3 month
|
54.5 units on a scale
Standard Deviation 23.6
|
54.6 units on a scale
Standard Deviation 23.6
|
|
Short Form-36 (SF-36) Vitality Subscale
6 month
|
55.1 units on a scale
Standard Deviation 24.6
|
55.8 units on a scale
Standard Deviation 23.9
|
|
Short Form-36 (SF-36) Vitality Subscale
12 month
|
54.4 units on a scale
Standard Deviation 23.6
|
55.2 units on a scale
Standard Deviation 24.3
|
|
Short Form-36 (SF-36) Vitality Subscale
24 month
|
57.9 units on a scale
Standard Deviation 24.8
|
55.9 units on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: US Patients in Economics Substudy
Observed Resource Use
Outcome measures
| Measure |
Usual Care
n=373 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=362 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Resource Utilization
Number of Hospitalizations
|
1.93 events
Standard Deviation 2.80
|
1.83 events
Standard Deviation 2.36
|
|
Resource Utilization
Number of ER only events
|
0.57 events
Standard Deviation 1.28
|
0.56 events
Standard Deviation 1.29
|
|
Resource Utilization
Number of Rehab facilities
|
0.06 events
Standard Deviation 0.35
|
0.06 events
Standard Deviation 0.25
|
|
Resource Utilization
Total admissions
|
2.56 events
Standard Deviation 3.64
|
2.45 events
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: US Patients with billing data
Observed Hospital-Based Cost.
Outcome measures
| Measure |
Usual Care
n=363 Participants
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=350 Participants
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Resource Utilization Cost
Hospital Costs
|
47,055 2016 US dollars
Standard Deviation 92,270
|
34,396 2016 US dollars
Standard Deviation 60,842
|
|
Resource Utilization Cost
Physician Fees
|
2,291 2016 US dollars
Standard Deviation 4,128
|
1,761 2016 US dollars
Standard Deviation 2,601
|
|
Resource Utilization Cost
Total Cost
|
49,346 2016 US dollars
Standard Deviation 96,082
|
36,157 2016 US dollars
Standard Deviation 63,110
|
Adverse Events
Usual Care
Serious events: 36 serious events
Other events: 157 other events
Deaths: 77 deaths
Biomarker-Guided Care
Serious events: 51 serious events
Other events: 178 other events
Deaths: 66 deaths
Serious adverse events
| Measure |
Usual Care
n=448 participants at risk
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 participants at risk
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Cardiac disorders
Symptomatic Hypotension
|
0.45%
2/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
1.6%
7/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Cardiac disorders
Symptomatic Bradycardia
|
0.00%
0/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
0.00%
0/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
1.3%
6/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
2.5%
11/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Renal and urinary disorders
Worsening renal function
|
2.0%
9/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
3.6%
16/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Investigations
Other Adverse Events
|
4.2%
19/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
3.8%
17/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
Other adverse events
| Measure |
Usual Care
n=448 participants at risk
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Usual Care: Usual Care
|
Biomarker-Guided Care
n=446 participants at risk
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Biomarker-guided care NT-proBNP: Device: NT-proBNP
|
|---|---|---|
|
Cardiac disorders
Symptomatic Hypotension
|
6.7%
30/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
8.3%
37/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Cardiac disorders
Symptomatic Bradycardia
|
0.67%
3/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
0.45%
2/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
4.9%
22/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
6.7%
30/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Renal and urinary disorders
Worsening renal function
|
18.5%
83/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
20.4%
91/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
|
Investigations
Other Adverse Events
|
4.2%
19/448 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
4.0%
18/446 • Randomization through completion of the final study visit at 24 months
SAEs and AEs of Interest that occur from randomization through completion of the final study visit will be reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place