Medtronic, Inc. (NYSE: MDT) today announced the initiation and first patient enrollment in a clinical study that will evaluate gaps in the implementation of evidence-based treatment guidelines among chronic heart failure patients post-hospital discharge. The IMPROVE HF Bridge Study will analyze approximately 120 patients from four different centers in the United States for a period of six months following their initial hospital stay. Patients will be cared for in the outpatient setting by either a primary care physician alone, or by both a heart failure specialist and primary care physician throughout the study.
"With primary care physicians managing the ongoing follow-up and treatment of heart failure patients once they are discharged from the hospital, this study will provide new insight on what is happening from a treatment perspective once this care is transferred," said Mihai Gheorghiade, M.D., principal investigator and professor of medicine and surgery, Feinberg School of Medicine at Northwestern University, Chicago. "It is our hope that through ongoing collaboration between cardiologists and primary care physicians, we can increase adherence to treatment guidelines and ultimately enhance the quality of care and reduce hospital readmission rates among heart failure patients."
The prospective, randomized study will also explore the feasibility of implementing Class I, Level A guideline recommendations set forth by the American College of Cardiology and American Heart Association. These include drug therapy (ACE inhibitors, beta-blockers), device therapy (implantable cardiac defibrillators, cardiac resynchronization therapy), heart failure education and anticoagulation for atrial fibrillation. Findings from this study will inform whether a larger trial to bridge the gap between guideline recommendations and actual practice will be initiated.