Join Clinical Trials for a Heart Valve Disorders
There are four valves in your heart that are constantly working to keep blood flowing in the right direction. They include the aortic valve, mitral valve, pulmonary valve, and tricuspid valve. Each time your heart beats, these four valves simultaneously open and close.
Occasionally, something can go wrong and one of the valves may not open or close as it should. As a result, the flow of blood through the heart is disrupted, which creates a chain reaction of disrupted blood flow through the body.
Stenosis occurs when a particular valve fails to open like it should. Regurgitation occurs when a valve doesn’t close properly and therefore has the potential to leak.
Stenosis and regurgitation can affect any of the four valves of the heart, and treatment is dictated by the particular valve that is affected and how severe the stenosis or regurgitation is. Some heart valve disorders are the result of underlying heart disease or result from a heart attack, while others occur when an infection attacks the valve itself.
Many heart valve disorders arise when the heart does not develop properly during fetal development, and are therefore considered congenital, or birth defects. In total, approximately five million individuals in the United States are diagnosed with some form of heart valve disease each year.
Receiving a diagnosis of heart valve disease can be a frightening experience, but it doesn’t have to be. Many heart valve diseases can be successfully treated and managed with medication and surgery, and even repaired with transplanted valves or tissues from humans and even animals.
Fortunately, research related to heart valve disease is abundant and thriving, with great strides being made every day with regard to improved methods of detection, diagnosis, treatment, and even prevention.
What Will Heart Valve Disorders Clinical Trials Be Like?
The types of tests and assessments used in heart valve disorder clinical trials will ultimately depend on the specific nature of the study and more importantly, which particular heart valve disease (or diseases) is/are being studied. 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
- 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 are associated with particular heart valve diseases and other heart diseases in general.
- 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 Heart Valve Disease Clinical Trial Protocol:
Specific examples of clinical trials for heart valve disease might include the following:
- A randomized clinical trial in which a specific beta-blocker (a drug used to regulate heart rhythm) is given to patients with mitral regurgitation who are scheduled to receive surgery to treat their disease. In this study, those patients would be compared with two other groups: patients with mitral regurgitation who receive surgery but who are not treated with the beta-blocker, and healthy volunteers (i.e., control subjects) who have no significant medical history and are not currently taking any medications. The purpose of this study would be to determine if receiving the beta-blocker provides any added benefit to those patients who receive surgery to treat their mitral regurgitation.
- A long-term study in which patients with aortic stenosis are treated with a cholesterol-lowering drug to determine if the drug is able to slow (or altogether stop) the narrowing of the aortic valve.
- A long-term study in which individuals who receive surgery to repair tricuspid valve regurgitation are followed over a 10 year period to assess their mortality, need for additional surgery, incidence of atrial fibrillation, and number of hospitalizations.
- A study in which patients with pulmonary stenosis, who receive valve replacement with a particular type of synthetic pulmonary valve, are followed for a six month period so that data can be collected by researchers to help establish the safety and efficacy of the synthetic valve.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. 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, 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 specific heart valve disease, any other history of heart disease, your 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 diagnosis of heart valve disease (e.g., pulmonary valve stenosis, aortic regurgitation)
- Your prior history of heart disease
- Your family 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 heart valve disease clinical trials, it is advisable for you to search using your specific diagnosis (e.g., mitral regurgitation, tricuspid regurgitation, aortic stenosis, etc.) combined with any of the following terms: “management,” “treatment,” “prevention,” “genetics,” “family history,” “birth defects,” “congenital,” “children,” “pediatric,” “infection,” “rehabilitation,” “transplant,” “pregnancy,” “replacement,” and “surgery.”
Current Search Term:
“Heart Valve Disorders”