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Diuretics, Hypertension, and Arrhythmias Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000525
Enrollment
233
Registered
1999-10-28
Start date
1986-07-31
Completion date
Unknown
Last updated
2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Arrest, Heart Diseases, Hypertension

Brief summary

To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.

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.

Interventions

DRUGhydrochlorothiazide
BEHAVIORALdiet, potassium supplementation
DRUGchlorthalidone
BEHAVIORALdiet, magnesium supplementation

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
35 Years to 70 Years
Healthy volunteers
No

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026