Hypertension Clinical Trial
To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
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.
;
Allocation: Randomized, Masking: Double-Blind
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