Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430833
Status:
UNKNOWN
Last Update Posted:
2007-02-02
First Post:
2007-01-31
Brief Title:
CHANCE - Candesartan in Hypertrophic Cardiomyopathy
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate The CHANCE a Double-Blind Placebo-Controlled Randomized Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients will be randomly assigned in 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None