CHANCE - Candesartan in Hypertrophic Cardiomyopathy - Full Text View

Sponsors and Collaborators:	Charles University, Czech Republic AstraZeneca
Information provided by:	Charles University, Czech Republic
ClinicalTrials.gov Identifier:	NCT00430833

Purpose

The primary hypothesis of the study is that treatment with AT1-R antagonist in patients with nonobstructive form of HCM will be first save, second will cause regression of myocardial hypertrophy.

Condition	Intervention	Phase
Hypertrophic Cardiomyopathy	Drug: candesartan	Phase II

MedlinePlus related topics: Cardiomyopathy

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter Study

Further study details as provided by Charles University, Czech Republic:

Detailed Description:

Patients will be randomly assigned in 1:1 ratio either to candesartan (target dose 32 mg once daily) or matching placebo. The initial dose of the study drug will be 8 mg once daily. Study drug dose will be then doubled as tolerated every 2 weeks while aiming for a target dose of 32 mg once daily.

Monitoring of blood pressure, serum creatinine, serum potassium and pressure gradient in LV outflow tract will be performed during dose increase.

Patients will be observed clinically at 3, 6, and 12 months after the maintenance dose was reached. Exercise tolerance will be assessed by bicycle ergometry, presence of malignant arrhythmias by Holter monitoring, extent of LV hypertrophy by 2-dimensional echocardiography, and LV outflow tract pressure gradient by Doppler echocardiography at baseline and 12-month follow-up.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

HCM defined on the basis of echocardiographic criteria showing a nondilated, hypertrophied left ventricle (any wall thickness > 15 mm) in the absence of known causes of LV hypertrophy hypertension or valvular disease

Exclusion Criteria:

Hypertrophic obstructive cardiomyopathy defined as presence of resting gradient in left ventricular outflow tract ³30 mmHg or in righ ventricular outflow tract ³15 mmHg at Doppler echocardiography;
Atrial fibrillation;
Treatment with ACE inhibitors or AT1-R antagonists any time in the past;
Contraindications to AT1-R antagonists;
Coronary artery disease, renal failure, hepatic disorders or serious intercurrent illness limiting survival; and
Poor echocardiographic image quality.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430833

Locations

Czech Republic
Cardiocenter, Third Faculty of Medicine, Charles University
Prague, Czech Republic, 10034

Sponsors and Collaborators

Charles University, Czech Republic

AstraZeneca

Investigators

Principal Investigator:

Martin Penicka, PhD

Charles University, Prague, Czech Republic

More Information

No publications provided by Charles University, Czech Republic

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Penicka M, Gregor P, Kerekes R, Marek D, Curila K, Krupicka J; Candesartan use in Hypertrophic And Non-obstructive Cardiomyopathy Estate (CHANCE) Study Investigators. The effects of candesartan on left ventricular hypertrophy and function in nonobstructive hypertrophic cardiomyopathy: a pilot, randomized study. J Mol Diagn. 2009 Jan;11(1):35-41. Epub 2008 Dec 12.

Study ID Numbers:	9164
Study First Received:	January 31, 2007
Last Updated:	January 31, 2007
ClinicalTrials.gov Identifier:	NCT00430833 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Heart Diseases
Constriction, Pathologic
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Cardiomyopathies

Heart Valve Diseases
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Hypertrophy
Cardiomyopathy, Hypertrophic
Candesartan
Aortic Valve Stenosis

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antihypertensive Agents
Cardiomyopathies
Pharmacologic Actions
Heart Valve Diseases
Angiotensin II Type 1 Receptor Blockers

Candesartan cilexetil
Hypertrophy
Aortic Stenosis, Subvalvular
Therapeutic Uses
Cardiomyopathy, Hypertrophic
Candesartan
Cardiovascular Diseases
Aortic Valve Stenosis

ClinicalTrials.gov processed this record on May 07, 2009