Diuretics, Hypertension, and Arrhythmias Clinical Trial

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000525
• Other study ID #: 44
• Secondary ID: R01HL036821
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: September 18, 2013
• Start date: July 1986

Study information

• Verified date: September 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. primary completion date: September 1989
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Death, Sudden
• Death, Sudden, Cardiac
• Heart Arrest
• Heart Diseases
• Hypertension

Intervention

Drug:
• hydrochlorothiazide

Behavioral:
• diet, potassium supplementation

• diet, magnesium supplementation

Drug:
• triamterene

• chlorthalidone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation