- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000525
Diuretics, Hypertension, and Arrhythmias Clinical Trial
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Stephen Hulley, University of California
Publications and helpful links
General Publications
- Siegel D, Cheitlin MD, Black DM, Seeley D, Hearst N, Hulley SB. Risk of ventricular arrhythmias in hypertensive men with left ventricular hypertrophy. Am J Cardiol. 1990 Mar 15;65(11):742-7. doi: 10.1016/0002-9149(90)91381-f.
- Chang SW, Fine R, Siegel D, Chesney M, Black D, Hulley SB. The impact of diuretic therapy on reported sexual function. Arch Intern Med. 1991 Dec;151(12):2402-8.
- Siegel D, Black DM, Seeley DG, Hulley SB. Circadian variation in ventricular arrhythmias in hypertensive men. Am J Cardiol. 1992 Feb 1;69(4):344-7. doi: 10.1016/0002-9149(92)90231-m.
- Siegel D, Hulley SB, Black DM, Cheitlin MD, Sebastian A, Seeley DG, Hearst N, Fine R. Diuretics, serum and intracellular electrolyte levels, and ventricular arrhythmias in hypertensive men. JAMA. 1992 Feb 26;267(8):1083-9.
- Siegel D, Cheitlin MD, Seeley DG, Black DM, Hulley SB. Silent myocardial ischemia in men with systemic hypertension and without clinical evidence of coronary artery disease. Am J Cardiol. 1992 Jul 1;70(1):86-90. doi: 10.1016/0002-9149(92)91395-k.
- Siegel D, Saliba P, Haffner S. Glucose and insulin levels during diuretic therapy in hypertensive men. Hypertension. 1994 Jun;23(6 Pt 1):688-94. doi: 10.1161/01.hyp.23.6.688.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Vascular Diseases
- Death
- Heart Diseases
- Hypertension
- Cardiovascular Diseases
- Heart Arrest
- Death, Sudden, Cardiac
- Death, Sudden
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Channel Blockers
- Diuretics, Potassium Sparing
- Sodium Chloride Symporter Inhibitors
- Epithelial Sodium Channel Blockers
- Hydrochlorothiazide
- Chlorthalidone
- Triamterene
Other Study ID Numbers
- 44
- R01HL036821 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
University College, LondonBritish Heart Foundation; Horizon 2020 - European CommissionRecruitingValvular Heart DiseaseUnited Kingdom
Clinical Trials on hydrochlorothiazide
-
Insel Gruppe AG, University Hospital BernCompleted
-
Mylan Pharmaceuticals IncCompletedHealthyUnited States
-
Sir Mortimer B. Davis - Jewish General HospitalNovartis PharmaceuticalsWithdrawnHypertension | DiabetesCanada
-
Daiichi Sankyo, Inc.CompletedEssential HypertensionFrance, Poland, Ukraine, Belgium, Germany, Spain, Bulgaria, Romania, Denmark, Russian Federation, Netherlands, Austria, Slovakia, Czechia
-
SanofiCompletedHypertensionIndia, Malaysia, Philippines, Singapore, Taiwan, Tunisia, Egypt, Korea, Republic of, Hong Kong, Indonesia, Morocco, Pakistan, Thailand, Vietnam
-
Daiichi Sankyo, Inc.Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyCompletedEssential HypertensionFrance, Poland, Ukraine, Germany, Spain, Bulgaria, Czechia
-
Spanish Society of Internal MedicineCompleted
-
IPCA Laboratories Ltd.Completed
-
University Hospital, Strasbourg, FranceSuspendedHypertension | End Stage Renal Disease | ProteinuriaFrance
-
University Medical Center GroningenNot yet recruitingADPKDNetherlands, United Kingdom, Belgium, Germany, France, Spain