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Clinical Trial Targets Devastating Heart Failure Diagnosis

Northwestern Medicine Researcher is Principal Investigator for International Trial

CHICAGO – Lynne Austin found she was increasingly out of breath doing even the simplest of tasks as 2015 came to a close.

She couldn’t walk more than a few steps at a time. She couldn’t breathe. Her health was rapidly deteriorating and she wasn’t sure she would get relief.

She had been diagnosed with heart failure with preserved ejection fraction (HFpEF). What was previously called diastolic heart failure, HFpEF (pronounced “huff-puff”) is a condition where the heart’s lower left upper chamber (left ventricle) is not able to fill properly with blood, so the blood backs up in the upper chamber (left atrium) and lungs, resulting in shortness of breath.

“All of a sudden it just hit me,” said Austin, 82, a Chicago resident. “I passed out coming out of a restaurant in January.”

With the encouragement of family members, Austin enrolled in the first international randomized trial designed to treat HFpEF using a medical device to relieve the pressure on her left heart, and lungs. Her participation in this trial, along with many other pioneering patients with HFpEF who participated in the trial, led to the second international randomized trial, REDUCE LAP-HF II.

The trial is co-led internationally by principal investigator Sanjiv Shah, MD, director of the T1 Center for Cardiovascular Therapeutics and director of the Heart Failure with Preserved Ejection Fraction Program at Northwestern Memorial Hospital.

“Heart failure is one of the biggest public health issues in the United States, and nearly half of all those with heart failure have a preserved ejection fraction (HFpEF), for which there are inadequate treatment options,” said Dr. Shah, who is a professor of medicine-cardiology at Northwestern University Feinberg School of Medicine. “By leading and taking part in the
REDUCE LAP-HF trials, we hope to make a significant difference for patients who suffer from this devastating condition.”

Mark Ricciardi, MD, director of cardiac catheterization and interventional cardiology at Northwestern Memorial, is the lead investigator for patients participating at Northwestern. Participants in the trial are randomized and may receive a dime-sized shunt device designed to lower the pressure in the left upper heart chamber. Those who do not receive the device initially will have the option to receive the device after two years.

For Dr. Ricciardi, REDUCE LAP-HF II is an important clinical trial that is putting Northwestern Medicine at the forefront of the safe and effective evaluation of transcatheter therapies; minimally invasive procedures performed through a small catheter that avoid open-heart surgery and typically take less than an hour.

“Our involvement in this and similar clinical trials positions Northwestern’s Bluhm Cardiovascular Institute at the forefront of medical breakthroughs,” said Dr. Ricciardi, an associate professor of medicine-cardiology at Feinberg. “We are constantly looking for the best, safest and most effective treatment options for our patients. By doing this type of clinical research, we also help the cardiovascular community at large learn how to help patients with heart disease.”

Austin learned in 2017 that she received the device, known as the InterAtrial Shunt Device, the world’s first transcatheter device designed to treat HFpEF.

Austin said her quality of life has improved dramatically more than a year after participating in the clinical trial.

“Just being able to function around my house has been an improvement,” she said. “I can shower, I can cook, and I can walk better.”

HFpEF is a condition where the heart muscle stiffens, which overloads the upper chamber of the heart that then backs up into the lungs, causing shortness of breath. Those suffering from HFpEF often can’t do basic daily tasks, cannot exercise, and are frequently hospitalized.

The condition differs from systolic heart failure, a condition with a number of successful treatments. Approximately 7 million people suffer from HFpEF in the United States and Europe, and the condition accounts for approximately half of all hospital admissions for people with heart failure. The trial is testing the safety and efficacy of the IASD System II to reduce elevated left atrial pressure in HFpEF patients.

The REDUCE LAP-HF I trial, which enrolled 44 patients, completed enrollment late 2016, and a larger clinical trial (REDUCE LAP-HF II) is now underway and aims to enroll nearly 400 patients.

To learn more about REDUCE LAP-HF II at Northwestern Medicine, visit http://treatmyheartfailure.com or contact Daniel Roshevsky, certified clinical research coordinator at the Bluhm Cardiovascular Institute Clinical Trials Unit at 312.695.3264 or droshevs@nm.org.

The Bluhm Cardiovascular Institute is part of the Northwestern Medicine health system, with multiple sites of care in Chicago and the region. Northwestern Memorial Hospital currently is ranked first in in the United States for heart failure survival and in the top 10 for the survival of heart attack and stroke, the three most dire cardiovascular health threats. Northwestern Memorial Hospital’s heart and heart surgery program is ranked seventh nationally and first in Chicago, Illinois and the surrounding states by U.S. News & World Report. For more information or to make an appointment with a cardiovascular specialist, visit heart.nm.org.