CHANCE - Candesartan in Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by Charles University, Czech Republic. Recruitment status was Active, not recruiting

First Received on January 31, 2007. No Changes Posted

Sponsor:	Charles University, Czech Republic
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

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 ClinicalTrials.gov Identifier (NCT Number):

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.

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

Additional relevant MeSH terms:

Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical

Candesartan
Candesartan cilexetil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012