Diuretics, Hypertension, and Arrhythmias Clinical Trial
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Arrest; Heart Diseases; Hypertension
Intervention: hydrochlorothiazide (Drug); diet, potassium supplementation (Behavioral); diet, magnesium supplementation (Behavioral); triamterene (Drug); chlorthalidone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Stephen Hulley, Affiliation: University of California
Summary
To determine whether hypertensive patients with ECG abnormalities and receiving
hydrochlorothiazide diuretics were at increased risk of sudden death.
Clinical Details
Study design: Allocation: Randomized, Masking: Double-Blind
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
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Related 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.
Starting date: July 1986
Last updated: September 18, 2013
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