Diuretics, Hypertension, and Arrhythmias Clinical Trial - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000525

Purpose

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

Condition	Intervention	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 III

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Cardiac Arrest Heart Diseases High Blood Pressure

Drug Information available for: Magnesium Hydrochlorothiazide Potassium chloride Chlorthalidone Triamterene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:

July 1986

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.

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000525

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Stephen Hulley

University of California

More Information

Publications:

Siegel D, Cheitlin MD, Black DM, Seeley D, Hearst N, Hulley SB. Risk of ventricular arrhythmias in hypertensive men with left ventricular hypertrophy. Am J Cardiol. 1990 Mar 15;65(11):742-7.

Chang SW, Fine R, Siegel D, Chesney M, Black D, Hulley SB. The impact of diuretic therapy on reported sexual function. Arch Intern Med. 1991 Dec;151(12):2402-8.

Siegel D, Black DM, Seeley DG, Hulley SB. Circadian variation in ventricular arrhythmias in hypertensive men. Am J Cardiol. 1992 Feb 1;69(4):344-7.

Siegel D, Hulley SB, Black DM, Cheitlin MD, Sebastian A, Seeley DG, Hearst N, Fine R. Diuretics, serum and intracellular electrolyte levels, and ventricular arrhythmias in hypertensive men. JAMA. 1992 Feb 26;267(8):1083-9.

Siegel D, Cheitlin MD, Seeley DG, Black DM, Hulley SB. Silent myocardial ischemia in men with systemic hypertension and without clinical evidence of coronary artery disease. Am J Cardiol. 1992 Jul 1;70(1):86-90.

Siegel D, Saliba P, Haffner S. Glucose and insulin levels during diuretic therapy in hypertensive men. Hypertension. 1994 Jun;23(6 Pt 1):688-94.

Study ID Numbers:	44
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000525
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Death
Heart Diseases
Triamterene
Chlorthalidone
Death, Sudden
Vascular Diseases

Heart Arrest
Death, Sudden, Cardiac
Hydrochlorothiazide
Arrhythmias, Cardiac
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Diuretics
Sodium Chloride Symporter Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009