CHANCE - Candesartan in Hypertrophic Cardiomyopathy
Information source: Charles University, Czech Republic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertrophic Cardiomyopathy
Intervention: candesartan (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Charles University, Czech Republic Official(s) and/or principal investigator(s):
Martin Penicka, PhD, Principal Investigator, Affiliation: Charles University, Prague, Czech Republic
Summary
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.
Clinical Details
Official title: Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter Study
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Cardiocenter, Third Faculty of Medicine, Charles University, Prague 10034, Czech Republic
Additional Information
Last updated: January 31, 2007
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