- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00011076
Pirfenidone to Treat Hypertrophic Cardiomyopathy
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:
- Electrocardiogram (ECG) - electrodes are attached to the heart to record the heart's 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.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Publications and helpful links
General Publications
- Chang AC, McAreavey D, Fananapazir L. Identification of patients with hypertrophic cardiomyopathy at high risk for sudden death. Curr Opin Cardiol. 1995 Jan;10(1):9-15. doi: 10.1097/00001573-199501000-00003.
- Bonow RO. Left ventricular diastolic function in hypertrophic cardiomyopathy. Herz. 1991 Feb;16(1):13-21.
- Beranek JT. Fibrosis in hypertrophic cardiomyopathy: its possible pathogenesis. J Am Coll Cardiol. 1990 Aug;16(2):519. doi: 10.1016/0735-1097(90)90615-v. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Hypertrophy
- Cardiomyopathies
- Cardiomyopathy, Hypertrophic
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- 010066
- 01-H-0066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Cardiomyopathy
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French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
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Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
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University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
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Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
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Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
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China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
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Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
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Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
-
Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
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Istituto Auxologico ItalianoRecruitingObstructive Hypertrophic CardiomyopathyItaly
Clinical Trials on Pirfenidone
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Jorge L PooCompletedCirrhosis, Liver | Liver Fibrosis | Chronic Liver Disease
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Capital Medical UniversityActive, not recruiting
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Fujian Medical University Union HospitalBeijing Continent Pharmaceutical Co, Ltd.RecruitingAcute Lung Injury | PreventionChina
-
Huilan ZhangUnknownPneumonia | Novel Coronavirus Pneumonia | PirfenidoneChina
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Beijing Continent Pharmaceutical Co, Ltd.Recruiting
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Hospices Civils de LyonRecruitingProgressive Idiopathic Pulmonary FibrosisFrance
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Genentech, Inc.Hoffmann-La RocheCompletedIdiopathic Pulmonary FibrosisUnited States
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Stanford UniversityGenentech, Inc.CompletedBronchiolitis Obliterans | Graft Vs Host DiseaseUnited States
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National Cancer Institute (NCI)CompletedRadiation FibrosisUnited States
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Hal ChapmanMassachusetts General Hospital; University of Michigan; University of Washington and other collaboratorsRecruitingIdiopathic Pulmonary FibrosisUnited States