Not Signed In -
Death And Dying |
Advance Directives; End of Life; Living Wills |
Clinical Trial: Diuretics, Hypertension, and Arrhythmias Clinical Trial
This study has been completed.
Purpose
To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Cardiovascular Diseases Death, Sudden, Cardiac Heart Arrest Heart Diseases Hypertension | Drug: hydrochlorothiazide Behavior: diet, potassium supplementation Behavior: diet, magnesium supplementation Drug: triamterene Drug: chlorthalidone | Phase III |
MedlinePlus related topics: Death and Dying; Heart Diseases; Heart Diseases--Prevention; High Blood Pressure; Vascular Diseases
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control
Study start: July 1986
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 - 70 Years, Genders Eligible for Study: Male
Criteria
Location Information
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.
Record last reviewed: January 2000
Last Updated: October 13, 2004
Record first received: October 27, 1999
ClinicalTrials.gov Identifier: NCT00000525
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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