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THIS STUDY FOR HEART FAILURE PREVENTION
A phase III, randomized, double-blind, parallel-group, placebo controlled, multicenter study to evaluate the effect of an investigational medicine in reducing cardiovascular outcomes in participants with HFpEF and HFmrEF
Study Location(s): Owensboro, KY
There are different types of heart failure. It depends on which part of the heart not working well. The focus of this study is on left-sided heart failure, and more specifically diastolic failure.
The heart pumps oxygen-rich blood from the lungs to the left atrium. Then it goes to the left ventricle, which pumps the blood to the rest of the body. The left ventricle does most of the heart’s pumping, so it’s larger than the other chambers. It is essential for the heart to function normally.
In left-sided, or left ventricular, heart failure, the left side must work harder to pump the same amount of blood. The amount of blood the heart can pump with each beat is measured by something called ejection fraction, or EF. A normal EF is about 55% to 60%.
Diastolic failure: The left ventricle can’t relax normally because the muscle has become stiff. The heart can’t fill with blood as is should during the time between each beat. This is also known as heart failure with preserved ejection, or HFpEF. When this happens, the EF is 50% or higher. Heart failure with mildly reduced ejection fraction (HFmrEF) is a newer concept. In this type of heart failure, the EF is between 41% and 49%. This places people with HFmrEF between the HFrEF and HFpEF groups. (source: American Heart Association)
The purpose of this study is to assess the effect of an investigational medicine compared with placebo in reducing the risk of cardiovascular outcomes events in participants with HFpEF and HFmrEF.
Participants must be at least 18 years old and have evidence of structural heart disease including left ventricular hypertrophy or left atrial enlargement and meet other criteria at the Visit 1 screening.
There is no cost to participate. Participants receive no cost investigational medicine and no cost health exams. Insurance is not required to participate. Reimbursement for participants for time and travel up to TBD.