Abnormal Heart Rhythm

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Abnormal Heart RhythmGeneral Purpose: 

Abnormal heart rhythms, or arrhythmias, refer to any disorder that affects your heart rate or rhythm. Sometimes your heart may noticeably skip a beat and create a ‘fluttering’ sensation of sorts within your chest. This can happen to anyone at any point during their lives and most of the time it is of no great significance. Sometimes, however, arrhythmias can signal that something is wrong.

When your heart consistently beats too fast (a condition known as tachycardia) or too slow (a condition known as bradycardia), or when the upper chambers of the heart (i.e., the atria) beat in a rapid, irregular pattern for an extended period of time (a condition called atrial fibrillation), you may be experiencing signs of underlying heart disease.

In fact, atrial fibrillation is a major cause of stroke. In addition, when the lower chambers of the heart (i.e., the ventricles) beat quickly and irregularly – an event known as ventricular fibrillation – they create an emergency situation in which blood pressure plummets and blood supply is cut off to the body’s vital organs. Ventricular fibrillation is a frequent cause of sudden death and requires prompt medical attention.

These abnormal heart rhythms can be caused by any number of things, including a heart attack, blood chemical imbalances, abnormal levels of certain hormones, as well as some medications.

Researchers are working hard to gain a better understanding of how heart cells communicate with each other, the causes of atrial and ventricular fibrillation, and improved methods of treating persistent arrhythmias. Research is also underway to study the genetics of heart diseases in general.

What Will Abnormal Heart Rhythm Clinical Trials Be Like?

The types of tests and assessments used in abnormal heart rhythm clinical trials will Abnormal Heart Rhythmultimately depend on the specific nature of the study and what aspects of heart disease are being investigated.

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
  • 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 Abnormal Heart Rhythm Clinical Trial Protocol:

Abnormal Heart RhythmSpecific examples of clinical trials for conditions characterized by abnormal heart rhythm might include the following:

  • A clinical trial that compares the use of a standard catheter-delivered treatment to a new anti-arrhythmia drug for the treatment of atrial fibrillation to determine which has a greater impact on reducing mortality and decreasing the rate of serious side effects.
  • A long-term study of dialysis patients to determine if an internally implanted arrhythmia monitoring device can identify the types and frequencies of arrhythmias experienced by this patient population (which has an extremely high rate of fatal arrhythmias when compared to the general population).
  • A study designed to determine the types of arrhythmias that pediatric patients experience while receiving general anesthesia during surgery.
  • A study to determine if patients who have implantable pacemakers and who take supplemental omega-3 fatty acids have a decreased risk of experiencing ventricular arrhythmia compared to patients who do not take the supplement.

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 Abnormal Heart Rhythmtrial 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 is being evaluated for the first time, 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 abnormal heart rhythm diagnosis (e.g., tachycardia, atrial fibrillation).
  • 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:

“cardiac arrhythmia,” “heart arrhythmia,” “ventricular fibrillation,” “atrial fibrillation,” “bradycardia,” “tachycardia,” “arrhythmia treatment,” “arrhythmia prevention,” “arrhythmia exercise,” “pediatric arrhythmia,” and “arrhythmia management.”

Current Search Term:

“Abnormal Heart Rhythm”

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