We have been very encouraged by our results to date, but only a randomized clinical trial will show how well our approach does relative to medication, and whether it stops these patients' downward spiral. The randomized clinical trial will establish how well this approach does at giving even the most advanced patients longer and better lives, and reducing their reliance on heart transplants. Heart failure most often arises as a result of other common diseases, including heart attack, narrowing of the arteries, high blood pressure and infection of heart muscle or valves. The weakened heart muscle deteriorates and cannot pump blood as efficiently, causing patients to feel tired and short of breath. Eventually, the heart fails.
Heart transplant is often the only option.
It will enroll 180 patients between the ages of 18 and 80 who have been diagnosed with Class III or Class IV congestive heart failure. Even patients who are not candidates for heart transplant, either because of age, diabetic condition, or Class III status, are eligible. Patients must have moderate or severe mitral valve problems that cause blood to leak, or regurgitate, backward from the left ventricle and collect in the left atrium. Such problems with the valve force the left ventricle to work even harder to pump blood into the body, causing it to eject less blood than normal with each beat - a measure known as ejection fraction. Participants in the trial will have ejection fractions less than 30 percent, as compared with a normal 70 percent.