View clinical trials related to Cardiomyopathies.
Filter by:The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
This study will examine the usefulness of a new test called an isoproterenol challenge in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) and family members who may have the disease but do not have clear-cut evidence of it. ARVC is a rare condition that runs in families. Heart muscle is replaced with fatty, scar-like tissue, especially in the right ventricle (lower pumping chamber of the heart), and can sometimes extend to the left ventricle (the main pumping chamber). The fat can interfere with the heartbeat, producing abnormal heart rhythms, such as ventricular tachycardia (VT) - a very fast heartbeat that can cause sudden death, especially in young people. Isoproterenol is a drug that increases heart rate and heart muscle contractions. In isoproterenol challenge, subjects are given increasing doses of the drug through a catheter (see details below) to try to produce an abnormal heart rhythm. ARVC is hard to diagnose with current tests. This study will see if isoproterenol challenge provokes VT in patients with the disease and can confirm the diagnosis; if it can detect the disease in family members better than currently available tests; and if it provokes abnormal rhythms in healthy control subjects. In addition, the study will explore the genetics of ARVC and determine whether infection could contribute to its development. Patients with ARVC, their family members, and normal volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and physical examination, electrocardiogram (EKG), treadmill and bicycle exercise testing, and an echocardiogram (ultrasound test of the heart). Participants undergo the following tests and procedures: - Blood tests - Blood is collected to study the genetics of ARVC, to test for evidence of old infections, and to measure brain natriuretic peptide - a hormone that can increase with development of heart failure. - Heart magnetic resonance imaging (MRI). This test looks at heart structure and function. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking sounds that occur during the scanning process. At some time during the test, the subject is given a contrast agent called gadolinium through a catheter (thin, flexible tube) in a vein to improve the scan pictures. The scan time varies from 30 to 90 minutes, with most scans lasting 60 minutes. (Control subjects do not undergo MRI.) - Isoproterenol challenge. Subjects are given increasing doses of isoproterenol through a catheter until the heart rate reaches 100 to 120 beats per minute for no more than 1 hour. A special EKG records heart rhythm during the test and an echocardiogram records right and left ventricular function. - QRST surface mapping EKG. This special EKG, done with 64 or 120 leads, maps abnormalities of heart rhythm and cardiac conduction during the isoproterenol challenge. These tests are like a regular EKG, except that more leads are placed on the chest, and on the back as well. Patients and family members who wish to have follow-up visits may return to the NIH Clinical Center once a year for 5 years for guidance about therapy based on clinical considerations and new information or investigations.
This study will examine how heart stiffness and a weak atrium affect exercise capacity and symptoms in patients with hypertrophic cardiomyopathy (HCM). The atrium is the booster pumping chamber of the heart that helps the ventricle (main pumping chamber), to fill properly. HCM is an inherited disease in which the ventricle becomes thickened and, in some patients, stiff. The stiffness makes it difficult for the ventricle to fill and empty, causing breathing difficulty, fatigue, and reduced exercise capacity. Scar formation and a weakened atrium can cause the heart to stiffen. Information gained from this study may guide doctors in prescribing medicines to reduce scarring or improve atrial function. Patients 21 years of age and older with hypertrophic cardiomyopathy may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram (EKG), blood tests, Holter monitor, and echocardiogram. A Holter monitor is a device about the size of a Walkman that is connected to three wires that are attached to the chest. It is worn for 24 hours to provide continuous monitoring of heart rhythm. An echocardiogram uses a small probe that emits sound waves to produce images of the heart. The probe is moved across the chest and the reflection of the sound waves from the chambers of the heart produce images showing the heart's thickness and function. Participants will undergo the following tests and procedures over 3 days: - Physical examination and echocardiogram. - Intravenous cannula insertion: A plastic tube is inserted into an arm vein for collecting blood samples to measure substances that the heart and circulatory system release at rest and during exercise. - Impedance cardiography: A small current of electricity is passed across the chest and electrodes similar to those used for an EKG test are placed to measure blood flow in the area of the current. - Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein either in the arm, under the collarbone, or in the neck and advanced to the right atrium and ventricle. The catheter remains in place during the echocardiogram tilt and bicycle exercise tests (see below). - Echocardiogram tilt test: The patient lies flat on a table. After a few minutes, the table is tilted so that the patient's head is just above his or her feet for a short while, then is positioned flat again, and then tilted so the feet are just above the head. Echocardiographic measurements and blood samples are taken at intervals to examine heart function during changes in posture. - Echocardiogram bicycle stress test: The patient exercises for as long as possible on a bicycle-like machine while lying on his or her back. Echocardiographic measurements and blood samples are taken at intervals during the test. - Treadmill stress test: The patient runs for as long as possible on a treadmill that increases in difficulty. The patient wears a facemask or mouthpiece through which small amounts of gases are added in order to measure the ability of the heart and lung to increase their effectiveness with exercise. - Digoxin loading: Only patients who demonstrate limited exercise capacity and for whom digoxin is not a risk will undergo this procedure. A medicine that makes the heart contract more strongly, digoxin is used to treat certain heart abnormalities. Patients are given doses of either digoxin or placebo (a look-alike injection with no active ingredient) at 4-hour intervals over a 24-hour period and then repeat the tilt test and the bicycle and treadmill exercise tests
In addition to medical treatment for heart failure (HF), a variety of non-pharmacological interventions have been demonstrated to benefit these patients. Some of these include systems for weight monitoring and medication reminders, exercise programs, and individually tailored evaluation and treatment plans with dietitians, social workers, psychologists, and nurse case managers. While many of these approaches have been shown to increase adherence to medication guidelines and result in decreased health care utilization, most rely heavily on a large team of specialized health care providers. It remains unknown whether or not an intervention with a lower intensity of specialized care using sophisticated automated computer tracking and Interactive Voice Response (IVR) techniques can impact the care of HF patients.
To identify new dilated cardiomyopathy genes by genetic linkage and mutational analyses.
This study will test the feasibility of a modified procedure for treating obstructive hypertrophic cardiomyopathy (OHC). Patients with OHC have a thickening of the heart muscle that obstructs blood flow out of the heart, causing breathlessness, chest pain, palpitations, tiredness, lightheadedness, and fainting. The current treatment for OHC is a procedure called alcohol septal ablation (also percutaneous transluminal septal ablation, or PTSA), which involves injecting a small amount of alcohol into a tiny artery that supplies the part of muscle causing blood flow obstruction. The success of PTSA is limited, however, by problems of heart anatomy and the ability to find the appropriate artery to inject. Modifying the procedure by injecting the alcohol through the wall of the lower right chamber of the heart may improve its safety and effectiveness. The new technique requires positioning a catheter (a flexible tube) into the appropriate area of the heart. This study will test the ability to accurately guide the catheter to that area. Patients with OHC 18 years of age and older who are scheduled to have a cardiac catheterization may be eligible for this study. At the end of the catheterization procedure, participants will undergo intra-cardiac echocardiographic imaging. For this test, one of the catheters placed in the femoral artery (at the top of the leg) for cardiac catheterization will be substituted for a larger one. Through this catheter, a special catheter will be introduced and advanced to the heart to provide images. This pilot feasibility study does not involve injection of alcohol.
This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the heart and blood vessels of patients with cardiovascular disease, including better detection of myocardial infarction (heart attack) and blockage of heart and leg arteries. Patients 18 years of age and older with cardiovascular disease may be eligible for this study. All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. For the procedure, the patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast' material may be injected into the patient s vein during part of the study to brighten the images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the electrical switching of the magnetic fields. They will be asked to hold their breath intermittently for 5 to 20 seconds during the scan. They will be monitored with an electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times with the person performing the scan. Patients can request to stop the study and come out of the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a test that uses sound waves to produce pictures of the heart and blood vessels-may be done to confirm the MRI findings. In addition, patients may undergo one or more of the following optional studies: - Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by increasing heart rate and heart function-to detect blockages in the coronary arteries (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart that are permanently damaged, perhaps by a previous heart attack. For this test, MRI pictures of the heart are taken before, during and after administration of dobutamine. Gadolinium may be injected during part of the study to brighten the images. An EKG will be used to monitor the heart during the procedure. - Vasodilator MRI - The procedure and objectives of this test are the same as those described for dobutamine stress MRI, except that this study uses dipyridamole or adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart. - Plethysmography MRI - This test determines the presence and severity of narrowing in arteries that supply blood to the leg. Blockage of these vessels often causes pain while walking. This study will compare plethysmography MRI with venous occlusion plethysmography, an older method of measuring blood flow in the legs. For venous occlusion plethysmography, a large blood pressure cuff is placed around the upper leg and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or twice outside the MRI scanner and once or twice inside the scanner. The scans are performed as described above for the dobutamine and vasodilator studies. The strain gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.
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.