Hypertension in Hemodialysis Patients (Aim 3)

Indiana University

Status and phase: Terminated; Phase 3

Conditions: Hypertension; Hemodialysis; Left Ventricular Hypertrophy

Treatments: Drug: Atenolol; Drug: Lisinopril

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00582114

R01DK062030 (U.S. NIH Grant/Contract)

NIH-NIDDK-5RO1-062030

0306-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.
4. Presence of LVH on echocardiogram defined as left ventricular mass index (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. Chronic obstructive pulmonary disorder (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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1

Active Comparator group

Description:

Atenolol

Treatment:

Drug: Atenolol

2

Experimental group

Description:

Lisinopril

Treatment:

Drug: Lisinopril