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Diuretics, Hypertension, and Arrhythmias Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000525
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of California, San Francisco
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double

Further study details as provided by University of California, San Francisco:

Enrollment: 233
Study Start Date: July 1986
Primary Completion Date: September 1989 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
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
OverallOfficial: Stephen Hulley University of California
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000525     History of Changes
Other Study ID Numbers: 44
R01HL036821 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
Last Verified: September 2013

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Heart Arrest
Death, Sudden
Death, Sudden, Cardiac
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