A Phase 2 interventional study of candesartan in Hypertrophic Cardiomyopathy, sponsored by Charles University, Czech Republic. Status unknown at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-02-02.
Sponsored by Charles University, Czech Republic · Phase 2 and Interventional
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.
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
Browse Cardiomyopathies studies →Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.
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Charles University, Czech Republic