Researchers at The Ohio State University Wexner Medical Center have begun enrolling patients with diastolic heart failure in a randomized double-blind trial that uses a new approach to relieve pressure in heart failure patients, aimed to help the heart pump more efficiently.
Dr. Rami Kahwash, a cardiologist at OSU, explained that diastolic heart failure happens when the heart becomes stiff and doesn’t relax enough to fill up completely between beats, causing blood to back up in and build pressure in the lungs.
Symptoms can include shortness of breath, exercise intolerance, fatigue and can be attributed to other conditions including depression and obesity.
The first randomized trial in the United States to study a new implant for patients with diastolic heart failure is underway. Diastolic heart failure means a patient’s heart beats normally, but doesn’t relax enough to completely fill with blood between beats. The condition ultimately makes the heart muscles rigid and, with no place to go, excess blood often seeps back to the lungs, causing serious breathing problems.
“Unfortunately, there have been no effective therapies for these patients for decades,” said Kahwash, a cardiologist and the study’s principal investigator at The Ohio State University Wexner Medical Center.
“Other than giving patients diuretics to help with fluid build-up, we haven’t had much to offer them. Hopefully, this device will change that.The device, a small dime-sized wire shunt, is implanted in the heart to help with excess buildup of blood. During a heart catheterization, we punch a hole in the wall of the heart and use this device to hold it open,” Kahwash said.
“That hole helps divert blood into the right atrium, acting somewhat like a dam, to relieve pressure and help the heart function more efficiently.”
Kahwash and Ohio State cardiologist Dr. Scott Lilly are part of a multi-center study that’s evaluating the dime-size implant intended to relieve the high pressure created by blood backing up from the heart into the lungs.
During a heart catheterization, doctors create a small path between the left and right upper chambers of the heart. They insert the tiny, inter-atrial shunt device to keep the path open to divert some of the blood from the high pressure left atrial chamber to the low pressure right atrial chamber. This could potentially lower the pressure in the left upper chamber, decrease the pressure in the lungs and thereby improve the symptoms of heart failure.
That’s exactly what Janet Wickham, of Senacaville, was hoping for when she volunteered for the trial. Neither she nor the doctors will know whether she got the device until the study is complete. The 69- year-old woman tries to stay active, but she said having DHF means sometimes it’s hard to leave her house.
Kahwash said finding new treatment options for DHF is crucial because it’s a growing public health problem. Risk factors include high blood pressure, diabetes, obesity and age. Kahwash said it’s estimated that within the next 5 years, DHF will account for more than half of all heart failure cases, and be responsible for more hospital admissions than systolic heart failure.
The trans-catheter interatrial shunt device is made by Corvia Medical Inc., which is funding the randomized trial. In all, 40 DHF patients will be randomized at up to 28 sites around the world. Those with heart failure can see if they may be potential candidates for the trial by going to: http://treatmyheartfailure.com/
Local residents with heart failure who want to see if they can be a candidate can visit this website.
“Once there, they can fill out a patient questionnaire which will tell them at the end if they're qualified or not,” said OSU media relation specialists Drew Schaar.
“Once the questionnaire is filled out, they choose the location that is most convenient for them and contact the representative that the site gives you at that location. Once contacted, the representative will be able to discuss the details of the study with the interested party.”