CHARLESTON, S.C. (WCSC) -- An ongoing trial at the Medical University of South Carolina is looking for a breakthrough for patients dealing with heart failure.
The condition is called heart failure with preserved ejection fraction, also called "HFpEF " or "Huff Puff".
MUSC Professor of Cardiology Dr. Sheldon Litwin has been the lead investigator in the study for the last decade. Litwin says stiff heart muscles create the condition. Litwin says the stiffening of the heart happens with the loss of elastic tissues but a gain of fibrous tissues in the body.
The stiffness leads to shortness of breath from blood getting into the lungs.
Litwin is studying a device called a cardiac shunt that aims to help regulate the blood pressure for patients dealing with the condition.
"When the pressure builds up too much on the left side, some of that blood will escape over to the right side, where it's tolerated better," Litwin says. "And so, we can keep the pressure low in the places where we want it, when we want it."
Litwin says around six to eight million people have heart failure across the nation. Half of that number suffers from "Huff Puff."
The professor of cardiology says the number of people with the condition continues to rise despite other forms of heart disease declining.
About 600 participants joined the pilot trial for the device. Litwin says patients who had the best response had less resistance to blood flow through their lungs and did not have pacemakers.
Jimmy McMillan was the third person in the United States and the first person in the Southeastern region to qualify for the clinical trial.
McMillan developed the condition after recovering from a triple-bypass heart surgery in 2009. The surgery followed McMillan's going through a heart attack in 2008.
Patients are not told whether they have the device implanted to avoid any possibilities of a placebo effect during this trial.
McMillan started his clinical trial journey in April 2016. He says he knew he had the device only three months in.
"I'm coming up on 10 years since I've received the device," McMillan says. "And I went from...11 years ago, not hardly being able to check my mail without having to sit down on the stoop to catch my breathe to, actually, I'm playing golf this afternoon, and I try to get in about 8,000 steps a day."
Doctors are looking to use about 300 participants for a second trial. Full enrollment for this trial will be completed in 2026.
The trial works by putting participants through a procedure for the device.
Litwin says getting the device approved by the U.S. Food and Drug Administration continues to be an ongoing effort.
He says the goal is to meet federal approval requirements by preventing hospitalizations and improving patient quality of life in order to begin using these devices outside of clinical trials.