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Trial NCT00000525

Resource URI: http://static.linkedct.org/resource/trials/NCT00000525
PropertyValue
linkedct:brief_title Diuretics, Hypertension, and Arrhythmias Clinical Trial
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3593>
linkedct:condition <http://static.linkedct.org/resource/condition/5692>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Male
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 70 Years
linkedct:eligibility_minimum_age 35 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000525
rdfs:label Trial NCT00000525
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000525
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 44
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/55669>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000525>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/28437>
linkedct:reference <http://static.linkedct.org/resource/reference/33508>
linkedct:reference <http://static.linkedct.org/resource/reference/33560>
linkedct:reference <http://static.linkedct.org/resource/reference/33985>
linkedct:reference <http://static.linkedct.org/resource/reference/38258>
linkedct:reference <http://static.linkedct.org/resource/reference/47901>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date July 1986
linkedct:study_design Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
rdf:type linkedct:trials
linkedct:verification_date January 2000