Hypertension in Hemodialysis Patients (Aim 3)

Phase 3

Terminated

Brief Summary: We will directly test the hypothesis that an initial strategy of lisinopril-based therapy will be more effective than atenolol-based therapy in causing regression of left ventricular hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar degree of BP reduction.

Detailed Description: This is a parallel group, active control, single-center, open-label, randomized controlled trial comparing the safety and efficacy of initial therapy with an angiotensin converting enzyme (ACE) inhibitor (lisinopril) vs. beta-blocker therapy (atenolol) each administered three times weekly after dialysis.

Recruitment & Eligibility

Inclusion Criteria

Patients on chronic hemodialysis for > 3 mos.
Compliance with hemodialysis treatments as defined by less than one missed dialysis per month
Hypertension as diagnosed by ambulatory blood pressure monitoring (ABPM) >135/75 mm Hg after participation in the ultrafiltration (UF) Trial, or those on no antihypertensive medications but unwilling to do UF Trial.
Presence of LVH on echocardiogram defined as left ventricular mass index (LVMi) >104 g/m2 in women and >116 g/m2 in men.
Willingness to give informed consent.

Exclusion criteria:

Vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months
Noncompliance with hemodialysis treatments
Known drug abuse
Chronic obstructive pulmonary disorder (COPD) requiring home oxygen
Congestive Heart Failure Class III or IV.
Body mass index > 40 kg/m2.
Known contraindication to atenolol (severe heart failure, bradycardia, bronchial asthma, intolerance or allergy) or lisinopril (cough, pregnancy, intolerance or allergy)

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
2	Lisinopril	Lisinopril
1	Atenolol	Atenolol

Primary Outcome Measures

Name	Time	Method
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Baseline, 6 months, 12 months	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.

Secondary Outcome Measures