OVERVIEW

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Heart disease is the leading cause of death in the U.S., Europe, and the majority of other countries around the world. Coronary heart disease (also called ischemic heart disease) is a type of heart disease in which the heart does not get enough oxygen and it accounts for the majority of heart disease-related deaths. It also leads to reduced quality of life, disability and lost productivity.

Many patients, despite maximal medical therapy, continue to have symptoms and reduced heart function (heart failure) from coronary heart disease. These patients have chronic heart failure. If you or someone you know has chronic heart failure, you may be interested in the ATHENA clinical trial.

The ATHENA clinical trial is designed to study the use of a patient’s own Adipose-Derived Regenerative Cells (ADRCs) to treat chronic heart failure from coronary heart disease in patients who are on maximal therapy and still have heart failure symptoms.

The ATHENA clinical trial will enroll 45 patients in multiple centers in the United States. The study doctor and team will assess whether or not you are eligible to participate in the study. However, the major qualifications to participate in this study are:

  • you have coronary heart disease (poor blood flow to the heart)
  • you are not a candidate for coronary artery bypass surgery, stents or balloon angioplasty
  • you are able to undergo a liposuction procedure (a procedure to remove approximately 1½  cups of fat tissue from your body)

If you think you or someone you know may be eligible for the ATHENA clinical trial please contact the study/intake coordinator at the most conveniently located study center.

The ATHENA Clinical Trial Design

Of the 45 patients to be enrolled, about 30 will receive their own ADRCs and about 15 will receive placebo. The study is a randomized, double-blind study which means that the choice of which investigational treatment (ADRCs or placebo) the patient receives will be made randomly (like tossing a coin) and neither the patient nor the study doctor will know which investigational treatment the patient received.

The clinical trial will involve the collection of fat from the patient’s body (liposuction), the preparation of ADRCs from that fat, and the subsequent injection of the patient’s own ADRCs (or placebo) into the damaged part of the patient’s heart. For more details on the procedure click here.

The study is designed to test whether ADRCs will improve heart function. In order to assess heart function, several measurements will be made, including peak oxygen consumption (VO2max), which measures how much physical exercise (gentle walking on a treadmill) a patient can perform, blood flow to the heart (perfusion), the amount of blood in the left ventricle at the end of contraction and relaxation (end-systolic and end-diastolic volumes), and the fraction of blood that is pumped during each contraction (ejection fraction). After the injection procedure, patients will be seen in the clinic for follow-up visits six times over the first 12 months; they will then be contacted by phone once a year for four years through to five years after the procedure.

Are there any risks with being in the ATHENA clinical trial?

The investigational ADRC Therapy being studied in the ATHENA clinical trial has not been sufficiently evaluated to determine whether the therapy provides true benefits. The information gathered during the ATHENA clinical trial will give doctors and scientists a better idea about whether there might be a benefit.  There are both known and unknown risks associated with the liposuction procedure, the investigational catheter-based procedure that will be used to inject ADRCs into a patient’s heart, and the use of investigational ADRC Therapy. The study doctor will discuss all of these risks with any patient interested in participating in the clinical trial.

You can learn more about the ATHENA trial at clinicaltrials.gov (NCT01556022).

You can learn more about participating in clinical trials at

Medline Plus – Clinical Trials

U.S. FDA Clinical Trials