Diuretics, Hypertension, and Arrhythmias Clinical Trial

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00000525

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

233

Enrollment

Study Details

Study Description

Brief Summary

To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Death, Sudden, Cardiac Heart Arrest Heart Diseases Hypertension	Drug: hydrochlorothiazide Behavioral: diet, potassium supplementation Behavioral: diet, magnesium supplementation Drug: triamterene Drug: chlorthalidone	Phase 3

Detailed Description

BACKGROUND:

The Multiple Risk Factor Intervention Trial (MRFIT) revealed an unexpected subgroup finding:

an association between diuretic therapy (especially with hydrochlorothiazide) and an increased rate of sudden death in hypertensive men with left ventricular hypertrophy and other ECG abnormalities. The Diuretics, Hypertension, and Arrhythmias Clinical Trial sought to determine whether the finding resulted from random variation or represented a serious toxic response to hydrochlorothiazide.

DESIGN NARRATIVE:

Randomized, double-blind. Following one month of withdrawal from all diuretics and repletion with oral potassium and magnesium, the study participants were randomized to two months of treatment with one of six treatment groups: hydrochlorothiazide; hydrochlorothiazide with oral potassium; hydrochlorothiazide with oral potassium and magnesium; hydrochlorothiazide and triamterene; chlorthalidone; or placebo. The main outcome measures were ventricular arrhythmias on 24-hour Holter monitoring and serum and intracellular potassium and magnesium levels.

Study Design

Study Type:

Interventional

Actual Enrollment :

233 participants

Allocation:

Randomized

Masking:

Double

Study Start Date :

Jul 1, 1986

Actual Primary Completion Date :

Sep 1, 1989

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Men, ages 35 to 70, with ECG abnormalities, diastolic blood pressure less than 95 mm Hg at entry.

Subjects had been treated for at least six months by their own physicians with hydrochlorothiazide (HCT), HCT and potassium supplementation, triamteren