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
|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|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Study Start Date :||July 1986|
|Actual Primary Completion Date :||September 1989|
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
|OverallOfficial:||Stephen Hulley||University of California|