Ochsner Participating in Largest Heart Failure Clinical Trial in U.S.
Enrollment for GUIDE-HF Clinical Trial Now Open
The John Ochsner Heart and Vascular Institute (JOHVI) is currently enrolling heart failure patients in the GUIDE-HF clinical trial – the largest heart failure (HF) medical device trial in the United States. Heart failure is the leading cause of hospitalization in America for adults over the age of 65 and Louisiana has the 5th highest death rate from cardiovascular disease in the country.
The GUIDE-HF clinical trial is an investigational device exemption (IDE) study aimed at evaluating improved survival and quality of life with Abbott’s CardioMEMS™ HF System, which supports heart failure management by measuring pulmonary artery pressure (PAP) from within the body. Building on previous clinical trials, the GUIDE-HF trial will study whether the implanted device can reduce heart failure hospitalization and improve survival and quality of life for people living with Class II, Class III or Class IV heart failure.
Once implanted via a minimally invasive procedure, the CardioMEMS™ HF System’s sensor transmits critical information about a patient’s pressure readings and heart failure status to a clinician, without the need for additional clinic or hospital visits. This data provides clinicians with the ability to detect worsening heart failure sooner and adjust treatment to reduce the likelihood that the patient will need to be hospitalized.
Data is transmitted once daily via an at-home patient electronic system, which comprises of an electronics unit and paddle-shaped antenna encased inside a pillow. The transmission takes approximately 2 to 3 minutes and reads the pressure measurement from the implanted sensor wirelessly. There is no pain or sensation for the patient who lays down on top of the pillow during the daily reading.
“There’s no question about it – the ability to monitor patients remotely and identify changes in pressure well before other symptoms begin to manifest is a gamechanger for treating patients suffering from heart failure,” said Selim Krim, MD, Cardiomyopathy and Heart Transplantation physician at JOHVI. Dr. Krim also serves as the principal investigator for this study.
Ochsner was the seventh site to open nationwide in this clinical trial. By 2023, the trial will include approximately 3,600 subjects at approximately 140 North American sites.
Ochsner is currently enrolling patients 18 years or older with Class II, III or IV heart failure in the GUIDE-HF clinical trial. Patients must have been hospitalized for heart failure within the last 12 months or present an elevated NT-proBNP – a peptide that indicates risk for congestive heart failure.
According to the American Heart Association, nearly 6 million Americans have heart failure and 900,000 new patients are diagnosed each year. The American Heart Association defines the classes of heart failure and common symptoms as follows:
- Class I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
- Class II – Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation or shortness of breath.
- Class III – Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation or shortness of breath.
- Class IV – Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
JOHVI is home to more than 50 cardiologists and surgeons who work closely with each patient to develop a customized healthcare plan that is both targeted and effective. Ochsner also participates in over 100 clinical trials for the goal of advancing knowledge of the mechanisms, treatments and diagnoses of cardiovascular disease. JOHVI was founded under the leadership of renowned cardiac surgeon, Dr. John L. Ochsner, Sr., who pioneered valve and coronary surgery.
To learn more about heart failure, visit www.ochsner.org/heartfailure. To learn more about the GUIDE-HF clinical trial call 504-842-0218.
About Ochsner Health System
Ochsner Health System is Louisiana’s largest non-profit, academic, healthcare system. Driven by a mission to Serve, Heal, Lead, Educate and Innovate, coordinated clinical and hospital patient care is provided across the region by Ochsner's 40 owned, managed and affiliated hospitals and specialty hospitals, and more than 100 health centers and urgent care centers. Ochsner is the #1 ranked hospital in Louisiana by U.S. News & World Report and is recognized as a “Best Hospital” across two specialty categories caring for patients from all 50 states and more than 70 countries worldwide each year. Ochsner employs nearly 25,000 employees and over 4,500 employed and affiliated physicians in over 90 medical specialties and subspecialties and conducts more than 700 clinical research studies. Ochsner Health System is proud to be a tobacco-free environment. For more information, please visit ochsner.org and follow us on Twitter and Facebook.