Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011076
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-02-09
Brief Title:
Pirfenidone to Treat Hypertrophic Cardiomyopathy
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study of Pirfenidone A Novel Anti-Fibrotic Drug in Symptomatic Patients With Hypertrophic Cardiomyopathy HCM Associated With Left Ventricular Diastolic Function
Status:
COMPLETED
Status Verified Date:
2003-04
Last Known Status:
None
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:
This study will examine the effectiveness of the drug pirfenidone Deskar in improving heart function in patients with hypertrophic cardiomyopathy HCM Stiffening of the heart muscle in patients with HCM impairs the hearts ability to relax and thus fill and empty properly This can lead to heart failure breathlessness and excessive fatigue The hearts inability to relax may be due to scarring or fibrosis in the muscle wall This study will test whether pirfenidone can reduce fibrosis improve heart relaxation and reduce abnormal heart rhythms
Men and women 20 to 75 years old with HCM may be eligible for this study Participants will undergo a physical examination blood tests and other tests and procedures described below to assess heart function When the tests are completed patients will be randomly assigned to one of two treatment groups One group will take a pirfenidone capsule and the other will take a placebo a look-alike pill with no active ingredient twice a day with meals for 6 months For the pirfenidone group the dose of drug will be increased gradually from 400 to 800 milligrams At the end of 6 months all patients will repeat the physical examination and heart tests that were done before starting medication These include
Electrocardiogram ECG - electrodes are attached to the heart to record the hearts electrical activity providing information on the heartbeat
Echocardiogram - a probe held against the chest wall uses sound waves to produce images of the heart providing information on the function of the heart chambers
24-hour Holter monitor - a 24-hour recording of the electrical activity of the heart monitors for abnormal heartbeats or conduction abnormalities
Magnetic resonance imaging MRI - Radiowaves and a strong magnetic field are used to produce images of the heart providing information on the thickness and movement of the heart muscle
Radionuclide angiogram - a radioactive tracer is injected into a vein and a special camera is used to scan the heart providing information on the beating motion of the heart Scans are obtained at rest and after exercise
Cardiac heart catheterization - a catheter thin plastic tube is inserted into a blood vessel in the groin and advanced to the heart to record pressures and take pictures inside the heart
Electrophysiology study - a catheter is inserted into a blood vessel in the groin and advanced to the heart to record electrical activity providing information on abnormal heart rhythms This procedure is done at the time of the heart catheterization
Cardiac biopsy - a catheter is inserted into a blood vessel in the groin and advanced to the heart to remove a small sample of heart muscle for microscopic examination This procedure is done at the end of the heart catheterization
Men and women 20 to 75 years old with HCM may be eligible for this study Participants will undergo a physical examination blood tests and other tests and procedures described below to assess heart function When the tests are completed patients will be randomly assigned to one of two treatment groups One group will take a pirfenidone capsule and the other will take a placebo a look-alike pill with no active ingredient twice a day with meals for 6 months For the pirfenidone group the dose of drug will be increased gradually from 400 to 800 milligrams At the end of 6 months all patients will repeat the physical examination and heart tests that were done before starting medication These include
Electrocardiogram ECG - electrodes are attached to the heart to record the hearts electrical activity providing information on the heartbeat
Echocardiogram - a probe held against the chest wall uses sound waves to produce images of the heart providing information on the function of the heart chambers
24-hour Holter monitor - a 24-hour recording of the electrical activity of the heart monitors for abnormal heartbeats or conduction abnormalities
Magnetic resonance imaging MRI - Radiowaves and a strong magnetic field are used to produce images of the heart providing information on the thickness and movement of the heart muscle
Radionuclide angiogram - a radioactive tracer is injected into a vein and a special camera is used to scan the heart providing information on the beating motion of the heart Scans are obtained at rest and after exercise
Cardiac heart catheterization - a catheter thin plastic tube is inserted into a blood vessel in the groin and advanced to the heart to record pressures and take pictures inside the heart
Electrophysiology study - a catheter is inserted into a blood vessel in the groin and advanced to the heart to record electrical activity providing information on abnormal heart rhythms This procedure is done at the time of the heart catheterization
Cardiac biopsy - a catheter is inserted into a blood vessel in the groin and advanced to the heart to remove a small sample of heart muscle for microscopic examination This procedure is done at the end of the heart catheterization
Detailed Description:
Left ventricular LV diastolic dysfunction and arrhythmias are important causes of morbidity and mortality in HCM These abnormalities are believed to be in part due to myocardial fibrosis which frequently complicates HCM Several studies indicate that pirfenidine can safely inhibit progression or cause regression of fibrotic lesions We therefore propose to perform a six-month study that examines the ability of pirfenidone to improve LV diastolic dysfunction exercise performance and electrophysiologic abnormalities in symptomatic patients with severe HCM
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-H-0066 | None | None | None |