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CHANCE - Candesartan in Hypertrophic Cardiomyopathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Charles University, Czech Republic.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430833
First Posted: February 2, 2007
Last Update Posted: February 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
Charles University, Czech Republic
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00430833     History of Changes
Other Study ID Numbers: 9164
First Submitted: January 31, 2007
First Posted: February 2, 2007
Last Update Posted: February 2, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action