Vanderbilt University Medical Center is one of roughly 60 study sites worldwide participating in RESPONDER-HF, a randomized clinical trial of an atrial shunt to treat heart failure patients.
More than half of the 26 million people worldwide who suffer from heart failure have a form of the disease called heart failure with preserved ejection fraction (HFpEF) that has few effective treatment options.
The trial is enrolling patients with HFpEF with no pulmonary vascular disease and no pacemakers who have been shown in prior studies to benefit most from this atrial shunt.
“A goal for treating HFpEF is to match patients, based on their individual characteristics, to therapies. The RESPONDER-HF trial is designed to do that,” said Deepak Gupta, MD, associate professor of Medicine in the Division of Cardiovascular Medicine and director of the Vanderbilt Translational and Clinical Cardiovascular Research Center.
“This study offers patients with HFpEF access to a simple, safe interventional option that may deliver enhanced quality of life and fewer visits to the hospital,” he said.
Patients with HFpEF may breathe normally at rest but quickly become breathless with physical activity (thus the nickname “huff-puff”) due to high pressure in the left ventricle and left atrium of the heart, which can transmit back to the lungs.
Study investigators hope to relieve that pressure by implanting a shunt between the two upper chambers of the heart to equalize the pressure when necessary.
If the patient is sitting and the pressure is normal, there is minimal or no flow across the device. When the left atrial pressure increases during exertion, blood flows through the shunt from the left into the right atrium, helping the patient to feel less short of breath.
