Clinical Trial Examines Remote Monitoring of Heart Failure Progression
User-friendly device engages patients while helping physicians personalize treatment
Heart failure plagues more than five million Americans and is the most common reason for hospitalization of patients 65 years and older. Currently, physicians monitor heart failure by examining symptoms of fatigue and shortness of breath over time to determine the best course of treatment. A new system in a research trial however may make monitoring heart failure progression easier and more precise. Physicians at Northwestern Memorial Hospital’s Bluhm Cardiovascular Institute are examining a device capable of measuring pressure in the heart remotely. The new technology, developed by device manufacturer St. Jude Medical, provides reports to subjects through a hand-held device. This allows them to adjust their heart failure medications based on physician orders and left atrial pressure (LAP), similar to how diabetes patients manage insulin therapy. Northwestern Memorial is one of only two sites in Illinois participating in the clinical trial, which could lead to a significant advancement in the management of heart failure, if the device proves to be safe and effective.
“Left atrial pressure is considered the gold standard for heart failure measurement, yet there is currently no way of obtaining this outside of a clinic or hospital,” said Robert Gordon, MD, cardiologist at the Bluhm Cardiovascular Institute. “This system is mobile and easy to use. If successful, we hope it encourages patients to be more involved in their care and provides physicians with the ability to personalize heart failure management.”
The device includes a few different components. A sensor in the heart transmits the left atrial pressure via a thin wire to a small antennae implanted under the subject’s skin. A portable, wireless, handheld device used by the subject provides a status update and directs the subject (as determined by the physician’s prescription) to take specific medications or make a lifestyle adjustment based on the left atrial pressure management. It’s intended to provide physicians with the ability to better personalize and optimize heart failure management using daily measures of a patient’s heart failure status.
“Heart failure is a serious disease and one that requires close monitoring because each patient is different,” said Gordon. “Tools like this could help engage the patient and allow us to tailor treatments to their unique needs.”
The Left Atrial Pressure Monitoring to Optimize Heart Failure (LAPTOP-HF) trial is being conducted with subjects who have a history of cardiomyopathy, a disease that weakens and enlarges the heart muscle. Subjects will be monitored for several years as part of the study, which is taking place at 75 sites across the country. Researchers hope to examine upward of 700 subjects. The system is being studied under an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA).
For more information about heart care at Northwestern Memorial, visit www.heart.nmh.org. To schedule an appointment please call 312-926-0779.
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