Baylor Scott & White Heart and Vascular Hospital – Fort Worth is actively recruiting for a study of cardiac contractility modulation (CCM) in a new group of heart failure patients. The AIM HIGHer study will evaluate the efficacy and safety of implantable CCM therapy in those with symptomatic heart failure and an ejection fraction (EF) between 40 and 60%.
Currently, CCM is only FDA-indicated as an option for heart failure patients with EF between 20 and 40%. With the AIM HIGHer study, patients with diastolic heart failure who aren’t doing well on medication therapy may now have an option for CCM therapy. It provides the only non-medication therapy for this group of patients.
“Diastolic heart failure is often the forgotten type of heart failure, and we may sometimes struggle with these patients,” says Aleem Mughal, MD, FHRS, a principal investigator for the study and medical director for electrophysiology at Baylor Scott & White Heart and Vascular Hospital – Fort Worth. “This study provides a novel device-based therapy for patients who have maximized their medical options.”
The CCM device helps improve left ventricular function in heart failure patients by using electrical stimulation to increase intracellular calcium. This provides an element of inotropy or a stronger contraction for the heart muscle.
AIM HIGHer will blind patients in a 1:1 fashion, with therapy either on or off after the device is implanted. Patients are then followed for 18 months after the implant. Study efficacy measures include endpoints such as improvement in heart failure status and a six-minute walk test.
The AIM HIGHer study is part of an overall commitment at Baylor Scott & White Heart and Vascular Hospital – Fort Worth to finding innovative treatment options to improve the care of all types of heart failure. For patients with diastolic heart failure, the condition can have significant effects on overall well-being, including frequent outpatient and hospital visits and increased healthcare costs.
“Heart failure represents a patient population with a very poor quality of life,” Dr. Mughal says. “By trying to help these patients, we’re working to keep them out of the hospital and make improvements in their long-term quality of life.”