Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000525
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
1999-10-27
Brief Title:
Diuretics Hypertension and Arrhythmias Clinical Trial
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL036821 | NIH | None | httpsreporternihgovquickSearchR01HL036821 |