Trial Outcomes & Findings for Hypertension in Hemodialysis Patients (Aim 3) (NCT NCT00582114)
NCT ID: NCT00582114
Last Updated: 2016-01-18
Results Overview
The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2016-01-18
Participant Flow
Participant milestones
| Measure |
Atenolol
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
58
|
46
|
|
Overall Study
NOT COMPLETED
|
42
|
54
|
Reasons for withdrawal
| Measure |
Atenolol
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
|---|---|---|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Kidney Transplant
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
16
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
6
|
|
Overall Study
Stopped by data safety monitoring board
|
19
|
20
|
Baseline Characteristics
Hypertension in Hemodialysis Patients (Aim 3)
Baseline characteristics by cohort
| Measure |
Atenolol
n=100 Participants
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
n=100 Participants
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
199 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/Ethnicity, Customized
Blacks
|
86 participants
n=5 Participants
|
86 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-blacks
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Etiology of chronic kidney disease
Diabetes mellitus
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Etiology of chronic kidney disease
Hypertension
|
54 participants
n=5 Participants
|
46 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Etiology of chronic kidney disease
Glomerulonephritis
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Etiology of chronic kidney disease
Polycystic kidney disease
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Etiology of chronic kidney disease
Other etiologies
|
13 participants
n=5 Participants
|
21 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Dialysis vintage
|
4.2 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
3.9 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
4.1 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Anuric
|
68 participants
n=5 Participants
|
66 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Education
|
12 years
STANDARD_DEVIATION 2 • n=5 Participants
|
12 years
STANDARD_DEVIATION 2 • n=7 Participants
|
12 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Comorbid conditions
Diabetes mellitus
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Comorbid conditions
Hospitalized heart failure
|
25 participants
n=5 Participants
|
37 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Comorbid conditions
Coronary artery disease
|
22 participants
n=5 Participants
|
31 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Comorbid conditions
Coronary revascularization
|
4 participants
n=5 Participants
|
15 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Comorbid conditions
Cerebrovascular disease
|
13 participants
n=5 Participants
|
20 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Comorbid conditions
Peripheral vascular disease
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Marital status
Single
|
53 participants
n=5 Participants
|
56 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Marital status
Married
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Marital status
Divorced/separated
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Marital status
Widowed
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Employed
Working
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Employed
Not working
|
67 participants
n=5 Participants
|
70 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Employed
Retired
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Income
< $25,000
|
84 participants
n=5 Participants
|
80 participants
n=7 Participants
|
164 participants
n=5 Participants
|
|
Income
>= $25,000
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Income
Refused
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Smoking
Current smoker
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Smoking
Non-smoker
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Alcohol
Drinks alcohol
|
27 participants
n=5 Participants
|
19 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Alcohol
Does not drink alcohol
|
73 participants
n=5 Participants
|
81 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Height
|
68.3 inches
STANDARD_DEVIATION 4.1 • n=5 Participants
|
67.6 inches
STANDARD_DEVIATION 3.7 • n=7 Participants
|
67.9 inches
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Weight
|
85.1 kg
STANDARD_DEVIATION 21.7 • n=5 Participants
|
80.9 kg
STANDARD_DEVIATION 24.3 • n=7 Participants
|
83 kg
STANDARD_DEVIATION 23.1 • n=5 Participants
|
|
Body mass index
|
28.4 kg/m^2
STANDARD_DEVIATION 7 • n=5 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 8.3 • n=7 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Access type
Fistula
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Access type
Graft
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Access type
Catheter
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Blood flow rate
|
394.3 mL/min
STANDARD_DEVIATION 30.9 • n=5 Participants
|
392.4 mL/min
STANDARD_DEVIATION 36.4 • n=7 Participants
|
393.4 mL/min
STANDARD_DEVIATION 33.7 • n=5 Participants
|
|
Dialysate flow rate
|
779.6 mL/min
STANDARD_DEVIATION 61.9 • n=5 Participants
|
761.3 mL/min
STANDARD_DEVIATION 82 • n=7 Participants
|
770.4 mL/min
STANDARD_DEVIATION 73 • n=5 Participants
|
|
Dialysis duration
Prescribed dialysis duration
|
239.4 minutes
STANDARD_DEVIATION 19 • n=5 Participants
|
239.4 minutes
STANDARD_DEVIATION 25.9 • n=7 Participants
|
239.4 minutes
STANDARD_DEVIATION 22.7 • n=5 Participants
|
|
Dialysis duration
Delivered dialysis duration
|
224.1 minutes
STANDARD_DEVIATION 34.7 • n=5 Participants
|
219.8 minutes
STANDARD_DEVIATION 33.7 • n=7 Participants
|
222 minutes
STANDARD_DEVIATION 34.2 • n=5 Participants
|
|
Urea reduction ratio
|
74 %
STANDARD_DEVIATION 8 • n=5 Participants
|
76 %
STANDARD_DEVIATION 8 • n=7 Participants
|
75 %
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Albumin
|
3.6 g/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.6 g/dL
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.6 g/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Hemoglobin
|
11.3 g/dL
STANDARD_DEVIATION 1.2 • n=5 Participants
|
11.3 g/dL
STANDARD_DEVIATION 1.4 • n=7 Participants
|
11.3 g/dL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Creatinine
|
10.3 mg/dL
STANDARD_DEVIATION 3.5 • n=5 Participants
|
10 mg/dL
STANDARD_DEVIATION 3.6 • n=7 Participants
|
10.1 mg/dL
STANDARD_DEVIATION 3.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. The analysis was performed by intention to treat, if the patient received at least one dose of the randomized drug regardless of the availability of a post-baseline echocardiogram.
The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.
Outcome measures
| Measure |
Atenolol
n=100 Participants
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
n=100 Participants
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
|---|---|---|
|
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.
LVMI Change from baseline, 6 months
|
-8.4 g/m^2
Standard Deviation 5.1
|
-3.4 g/m^2
Standard Deviation 5.5
|
|
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.
LVMI Change from baseline, 12 months
|
-21.5 g/m^2
Standard Deviation 5.7
|
-15.1 g/m^2
Standard Deviation 6.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yrCardiovascular events were counted by subject and included the following: myocardial infarction (MI), stroke, hospitalization for congestive heart failure (CHF), hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. Adverse events reported are those during the course of 12 months of participation in the trial. All serious adverse events were adjudicated by R.A. and A.D.S. who were masked to the drug assignment at the time of adjudication. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. The cardiovascular event rate was calculated by treatment group assignment. Incidence rate ratio (IRR) by treatment was then determined along with the 95% confidence intervals (95% CIs). As a post hoc analysis, we also determined the narrower definition of cardiovascular events per group that included MI, stroke, CHF, or cardiovascular death.
Outcome measures
| Measure |
Atenolol
n=100 Participants
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
n=100 Participants
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
|---|---|---|
|
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination
Incidence rate, cardiovasular events
|
24.6 events/100 patient-years
|
58 events/100 patient-years
|
|
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination
Incidence rate, combined MI, stroke, CHF, CV death
|
13.5 events/100 patient-years
|
31 events/100 patient-years
|
|
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination
Incidence rate, congest heart failure
|
6.2 events/100 patient-years
|
20.2 events/100 patient-years
|
|
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination
Incidence rate, all-cause hospitalizations
|
89.9 events/100 patient-years
|
144.3 events/100 patient-years
|
Adverse Events
Atenolol
Serious events: 58 serious events
Other events: 44 other events
Deaths: 0 deaths
Lisinopril
Serious events: 70 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atenolol
n=100 participants at risk
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
n=100 participants at risk
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
|---|---|---|
|
Infections and infestations
Infections
|
24.0%
24/100 • Number of events 30
|
20.0%
20/100 • Number of events 29
|
|
Renal and urinary disorders
Access-related
|
17.0%
17/100 • Number of events 24
|
19.0%
19/100 • Number of events 30
|
|
Nervous system disorders
Central nervous system
|
3.0%
3/100 • Number of events 3
|
3.0%
3/100 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer-related complications
|
2.0%
2/100 • Number of events 4
|
2.0%
2/100 • Number of events 3
|
|
Cardiac disorders
Angina
|
0.00%
0/100
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Arrhythmia
|
2.0%
2/100 • Number of events 2
|
3.0%
3/100 • Number of events 5
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/100
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Congestive heart failure
|
5.0%
5/100 • Number of events 5
|
10.0%
10/100 • Number of events 15
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
2/100 • Number of events 2
|
3.0%
3/100 • Number of events 3
|
|
Cardiac disorders
Peripheral vascular disease
|
1.0%
1/100 • Number of events 1
|
5.0%
5/100 • Number of events 6
|
|
Cardiac disorders
Revascularization
|
3.0%
3/100 • Number of events 4
|
4.0%
4/100 • Number of events 4
|
|
Cardiac disorders
Stroke
|
2.0%
2/100 • Number of events 2
|
2.0%
2/100 • Number of events 2
|
|
Cardiac disorders
Valve replacement surgery
|
1.0%
1/100 • Number of events 1
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Cardiovascular death
|
2.0%
2/100 • Number of events 2
|
3.0%
3/100 • Number of events 3
|
|
General disorders
Noncardiovascular death
|
2.0%
2/100 • Number of events 2
|
1.0%
1/100 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fractures
|
7.0%
7/100 • Number of events 7
|
1.0%
1/100 • Number of events 1
|
|
Endocrine disorders
Parathyroidectomy
|
3.0%
3/100 • Number of events 3
|
1.0%
1/100 • Number of events 1
|
|
Hepatobiliary disorders
Biliary-related
|
1.0%
1/100 • Number of events 1
|
2.0%
2/100 • Number of events 2
|
|
Gastrointestinal disorders
Bowel-related
|
3.0%
3/100 • Number of events 3
|
5.0%
5/100 • Number of events 5
|
|
General disorders
Falls
|
6.0%
6/100 • Number of events 6
|
3.0%
3/100 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
2.0%
2/100 • Number of events 4
|
5.0%
5/100 • Number of events 7
|
|
General disorders
Hypertensive crisis
|
3.0%
3/100 • Number of events 3
|
10.0%
10/100 • Number of events 11
|
|
Endocrine disorders
Hyperglycemia
|
1.0%
1/100 • Number of events 2
|
3.0%
3/100 • Number of events 3
|
|
Renal and urinary disorders
Hyperkalemia
|
3.0%
3/100 • Number of events 3
|
10.0%
10/100 • Number of events 10
|
|
Endocrine disorders
Hypoglycemia
|
2.0%
2/100 • Number of events 3
|
4.0%
4/100 • Number of events 4
|
|
General disorders
Hypotension with hospitalization
|
6.0%
6/100 • Number of events 8
|
5.0%
5/100 • Number of events 5
|
|
General disorders
Miscellaneous
|
12.0%
12/100 • Number of events 14
|
18.0%
18/100 • Number of events 24
|
Other adverse events
| Measure |
Atenolol
n=100 participants at risk
Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
Lisinopril
n=100 participants at risk
Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.
|
|---|---|---|
|
General disorders
Fatigue
|
20.0%
20/100 • Number of events 25
|
6.0%
6/100 • Number of events 12
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
5.0%
5/100 • Number of events 6
|
6.0%
6/100 • Number of events 6
|
|
Infections and infestations
Upper respiratory infection
|
1.0%
1/100 • Number of events 1
|
2.0%
2/100 • Number of events 4
|
|
General disorders
bradycardia
|
2.0%
2/100 • Number of events 3
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Intradialytic hypotension
|
6.0%
6/100 • Number of events 7
|
4.0%
4/100 • Number of events 4
|
|
General disorders
tachycardia
|
1.0%
1/100 • Number of events 1
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Dialysis access-related events
|
0.00%
0/100
|
1.0%
1/100 • Number of events 1
|
|
General disorders
Hypertension
|
1.0%
1/100 • Number of events 1
|
2.0%
2/100 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/100 • Number of events 2
|
2.0%
2/100 • Number of events 2
|
|
General disorders
Other
|
19.0%
19/100 • Number of events 23
|
17.0%
17/100 • Number of events 29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place