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  • Einstein Medical Center Philadelphia Joins Clinical Trial to Test Treatment for Heart Failure Patients

    Published: 02/10/2014

    Einstein Medical Center Philadelphia is participating in a clinical trial for patients with heart failure, called LAPTOP-HF, an acronym for Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy. The purpose of the study is to evaluate the safety and effectiveness of an implantable device called LAP-HF Management System which provides information on the pressure within the heart.

    The information allows patients to adjust their medications daily based on a physician-directed prescription plan and their current Left Atrial Pressure (LAP). An elevation in LAP is a warning that fluid will develop in the lungs and result in worsening heart failure symptoms. Approximately 90 percent of patients admitted to a hospital for heart failure have pulmonary congestion related to elevated LAP.

    “The aim of the study is to determine if this type of live feedback can have an impact in improving heart failure treatment by engaging patients in managing their care, and ultimately, be effective in keeping patients out of the hospital,” says Sumeet Mainigi, MD, FACC, FHRS, Associate Director of Electrophysiology at Einstein Medical Center Philadelphia and lead investigator for the study at Einstein.

    The LAPTOP-HF clinical trial is the first large-scale study utilizing this type of device to treat heart failure, a condition that affects more than five million Americans and is the most common cause of hospitalization in the United States. This approach is very similar to how people with diabetes learn to self-monitor their glucose and insulin levels and make adjustments to their diet and medications accordingly.

    The study involves implanting the LAP-HF Management System device under the skin which is connected to a pressure sensor placed into the left upper chamber of the heart.

    The sensor continually measures heart pressures and if the pressure reaches a certain level, the doctors get alerted via a website used for patients, and the patient also gets an alert on a special handheld device that will ask him/her to take additional medications. “The technology means doctors no longer have to guess how much fluid our patients are holding on to and we can intervene before a problem arises,” says Einstein cardiologist Behnam Bozorgnia, MD, a heart failure specialist who is working closely with Dr. Mainigi on the study.

    Heart failure is a chronic condition where the heart cannot pump enough blood and oxygen to support other organs in the body. The condition results in shortness of breath during activities, difficulty breathing when lying down, swelling in the feet, legs, ankles or stomach, and feeling tired and weak. For many people, their symptoms of heart failure worsen over time, and they have repeated hospitalizations.

    The LAPTOP-HF trial is sponsored by St. Jude Medical, a medical device company headquartered in St. Paul, MN. Seventy-five centers across the country are participating in the trial and the goal is to enroll 730 patients nationally. The aim is to enroll between 10 and 20 patients at Einstein Medical Center Philadelphia, the only active site in the Philadelphia area. For more information about the clinical trial at Einstein Medical Center Philadelphia, call 215-456-7022.

    In another effort to improve care for patients with heart failure, Einstein Medical Center Philadelphia is one of 11 hospitals in the country selected to participate in the American College of Cardiology’s Patient Navigator Program to support patients with heart failure or unstable angina, and those who have had a heart attack. This will be the first program of its kind in cardiology designed to keep patients healthy and reduce the rate of readmission after they are discharged from a hospital.

  • Communications Team