Diuretics, Hypertension, and Arrhythmias Clinical Trial

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ClinicalTrials.gov Identifier: NCT00000525

Recruitment Status : Completed

First Posted : October 28, 1999

Last Update Posted : September 19, 2013

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Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

University of California, San Francisco

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	233 participants
Allocation:	Randomized
Masking:	Double
Study Start Date :	July 1986
Actual Primary Completion Date :	September 1989

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	35 Years to 70 Years (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000525

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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OverallOfficial:	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. doi: 10.1016/0002-9149(90)91381-f.

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. doi: 10.1016/0002-9149(92)90231-m.

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. doi: 10.1016/0002-9149(92)91395-k.

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. doi: 10.1161/01.hyp.23.6.688.

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ClinicalTrials.gov Identifier:	NCT00000525
Other Study ID Numbers:	44 R01HL036821 ( U.S. NIH Grant/Contract )
First Posted:	October 28, 1999 Key Record Dates
Last Update Posted:	September 19, 2013
Last Verified:	September 2013

Additional relevant MeSH terms:

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Hypertension Cardiovascular Diseases Heart Diseases Heart Arrest Death, Sudden, Cardiac Death, Sudden Vascular Diseases Death Pathologic Processes Hydrochlorothiazide Chlorthalidone	Triamterene Antihypertensive Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Epithelial Sodium Channel Blockers Sodium Channel Blockers Diuretics, Potassium Sparing

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