525
Last Update Posted: 2013-09-19
Recruiting has ended
Males accepted | 35 Years-70 Years |
233 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Diuretics, Hypertension, and Arrhythmias 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.
Eligibility
Relevant conditions:
Cardiovascular Diseases
Death, Sudden, Cardiac
Heart Arrest
Heart Diseases
Hypertension
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
No valid contacts available
Data sourced from ClinicalTrials.gov