About Cardiomyopathy Clinical Trials (Click to Open)

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Cardiomyopathy Clinical TrialsGeneral Purpose: 

Cardiomyopathy is a general term used to describe various diseases affecting the heart muscle. Cardiomyopathy results in the heart muscle becoming thick, rigid, or enlarged. Sometimes it can even be replaced by scar tissue.

Cardiomyopathy is dangerous because as it worsens, the heart becomes weaker and gradually loses its ability to beat on a regular rhythm and pump blood efficiently. As a result, heart failure or abnormal heart rhythms can develop, leading to a number of other potential complications throughout the body.

Cardiomyopathy can either be acquired (meaning it develops as a result of a specific disease, health condition, or some other factor), or it can be inherited. There are four main types of cardiomyopathy: dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and arrhythmogenic right ventricular dysplasia (ARVC).

If you have been diagnosed with one of these cardiomyopathies, you may be seeking out a clinical trial for the purposes of treating your heart disease or helping to control the symptoms that it causes for you. Take comfort in the fact that there is a wealth of research underway examining a multitude of aspects related to cardiomyopathy, including research aimed at improved diagnosis, prevention, and treatment.

What Will Cardiomyopathy Clinical Trials Be Like?

The types of tests and assessments used in cardiomyopathy clinical trials will ultimately depend on the specific nature of the study and what aspects of cardiomyopathy are being Cardiomyopathy Clinical Trialsinvestigated. Provided below is a list of frequent procedures and tests used to evaluate the heart, heart functioning, and its impact on the body in general, many of which may be incorporated for use in clinical trials:

  • Physical exam
  • Detailed family history of heart diseases.
  • Genetic testing to look for evidence of cardiomyopathy-related genetic mutations in you and/or your family members.
  • Cardiac catheterization: a procedure during which a long, thin, and flexible tube (i.e., catheter) is inserted into a blood vessel in the arm, upper thigh, or neck and threaded through until it reaches your heart. This allows doctors to perform diagnostic tests and treatments, as well as to evaluate blockages in the blood vessels.
  • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans: these are non-invasive imaging procedures, similar to an x-ray, that allow doctors to take detailed pictures of your heart.
  • Coronary angiography: a procedure during which a dye is injected into a vein in your arm and then viewed using a special x-ray machine, CT scanner, or MRI machine. This allows doctors to view the insides of the arteries that provide blood to your heart. Angiography may also be used to evaluate other blood vessels throughout the body.
  • Echocardiography (“echo”): a painless procedure that uses ultrasound to create moving pictures of your heart, which allow doctors to see its size, shape, and how well it is working. During a procedure known as transesophageal echocardiography, a long, thin ultrasound probe is guided down the throat into the esophagus, which is directly behind the heart, in order to obtain more detailed pictures.
  • Electrocardiogram (EKG, or ECG): a straightforward and painless procedure that records the electrical activity of the heart. This test tells doctors how fast your heart is beating, the regularity (or irregularity) of your heart rhythm, and strength and timing of the electrical signals that constantly pass through the heart.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Blood tests to look for chemical markers that indicate the presence of heart disease. Examples of these markers include troponin, CK-MB enzyme, myoglobin, hs-CRP, and BNP or NT-proBNP, pH, oxygen, and carbon dioxide.
  • Nuclear heart scan: a test that uses a small but safe amount of a radioactive compound, injected into your body through a vein in the arm. This compound then travels to the heart and allows special cameras to take detailed pictures of the heart to evaluate 1) blood flow; 2) damaged heart muscle; and 3) pumping ability and efficiency.
  • Stress test: a test performed while you exercise (usually by walking or running on a treadmill, or pedaling a stationary bicycle), which allows doctors to evaluate how your heart works during episodes of physical stress.
  • Pain and quality of life assessments, as well as exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Cardiomyopathy Clinical Trial Protocol:

Specific examples of clinical trials for the various forms of cardiomyopathy might include the following:

  • A clinical trial that examines the effectiveness of a new drug in improving heart function in patients with hypertrophic cardiomyopathy. In this trial, some patients would receive the new drug while others would receive a placebo (see text below protocol examples for additional information).
  • A study designed to evaluate the effectiveness of a new echocardiography technique for assessing left ventricular dysfunction in patients with restrictive cardiomyopathy.
  • A study designed to evaluate the usefulness of a new procedure for diagnosing ARVC in patients with a known diagnosis of the disease, their first-degree relatives, and normal healthy volunteers.
  • A randomized clinical trial to determine if standard therapy plus injections of patients’ bone-marrow-derived stem cells is more effective at repairing heart muscle damage than standard therapy plus a placebo injection in pediatric patients with dilated cardiomyopathy.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” Cardiomyopathy Clinical Trialstreatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, such as the first and fourth clinical trial examples provided above, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your history of heart disease, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your specific form of cardiomyopathy (e.g., restrictive or dilated)
  • Your prior history of heart disease
  • Your prior history of treatment for heart disease (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels

Suggested Search Terms:

Once you are ready to begin your search for cardiomyopathy clinical trials, you will be best served to search using your specific cardiomyopathy diagnosis. For example, if you have restrictive cardiomyopathy, your search might use any of the following combinations of terms: “restrictive cardiomyopathy treatment,” “restrictive cardiomyopathy diagnosis,” “restrictive cardiomyopathy genetic,” “restrictive cardiomyopathy children,” “restrictive cardiomyopathy pediatric,” “restrictive cardiomyopathy symptoms,” and “restrictive cardiomyopathy management.”

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