Pirfenidone to Treat Hypertrophic Cardiomyopathy
|ClinicalTrials.gov Identifier: NCT00011076|
Recruitment Status : Completed
First Posted : February 12, 2001
Last Update Posted : March 4, 2008
|First Submitted Date ICMJE||February 9, 2001|
|First Posted Date ICMJE||February 12, 2001|
|Last Update Posted Date||March 4, 2008|
|Study Start Date ICMJE||February 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00011076 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Pirfenidone to Treat Hypertrophic Cardiomyopathy|
|Official Title ICMJE||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|
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 heart's ability to relax and thus fill and empty properly. This can lead to heart failure, breathlessness and excessive fatigue. The heart's 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:
|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 Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Hypertrophic Cardiomyopathy|
|Intervention ICMJE||Drug: Pirfenidone|
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||April 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Male or female patient aged 20 to 75 years.
Cardiac symptoms: New York Heart Association Functional Class II-IV despite medical therapy.
Maximum LV wall thickness greater than 15 mm assessed by echo or MRI.
Mean pulmonary capillary wedge pressure of greater than or equal to 18 mm Hg and/or LV end-diastolic pressure of greater than or equal to 18 mm Hg.
LV outflow tract gradient greater than 40 mm Hg by cardiac catheterization.
Coronary artery disease (greater than 50% arterial luminal narrowing of a major epicardial vessel).
Chronic atrial flutter/fibrillation
Pregnancy and breast-feeding.
Treatment with immunosuppressant medication in last 90 days.
Active neoplastic disease.
Significant renal (serum creatinine greater than 1.5 x upper reference limit) or hepatic (transaminases greater than 2 x upper reference limit) dysfunction.
Use of over-the-counter medications, or herbal therapies that may be cardioactive.
|Ages ICMJE||Child, Adult, Older Adult|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00011076|
|Other Study ID Numbers ICMJE||010066
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP