Hypertension in Hemodialysis Patients (Aim 3)

Condition(s) targeted: Hemodialysis; Hypertension; Left Ventricular Hypertrophy

Intervention: Lisinopril (Drug); Atenolol (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Rajiv Agarwal, MD, Principal Investigator, Affiliation: Indiana University

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 LVH over one year in patients with hemodialysis hypertension despite similar degree of BP reduction.

Official title: Hypertension in Hemodialysis Patients

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary end point is the regression of LVH by echocardiographic criteria from baseline to 1 year.

Secondary outcome:

Regression of LVH at 6 months

ITT average reduction in LVM indexed for body surface area from baseline to one year in two groups and adjusted for biologically important covariates, such as age, gender, and ambulatory BP.

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 ACE inhibitor (lisinopril) vs. beta-blocker therapy (atenolol) each administered three times weekly after dialysis.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients on chronic hemodialysis for > 3 mos.

2. Compliance with hemodialysis treatments as defined by less than one missed dialysis per month

3. Hypertension as diagnosed by ABPM >135/75 mm Hg after participation in the UF Trial, or those on no antihypertensive medications but unwilling to do UF Trial.

4. Presence of LVH on echocardiogram defined as LVMi >104 g/m2 in women and >116 g/m2 in men.

5. Willingness to give informed consent.

Exclusion criteria:

1. Vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months

2. Noncompliance with hemodialysis treatments

3. Known drug abuse

4. COPD requiring home oxygen

5. Congestive Heart Failure Class III or IV.

6. Body mass index > 40 kg/m2.

7. Known contraindication to atenolol (severe heart failure, bradycardia, bronchial asthma, intolerance or allergy) or lisinopril (cough, pregnancy, intolerance or allergy)

Indiana University, Indianapolis, Indiana 46202, United States; Recruiting
Rajiv Agarwal, MD, Phone: 317-988-2241

Starting date: August 2005
Last updated: June 6, 2008