Trial of CRT Device Use in Heart Failure Patients with Milder Symptoms Completes Enrollment
March 19, 2009 – The enrollment phase of the RAFT clinical trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) is complete, announced Medtronic Inc.
The trial studies the impact of cardiac resynchronization therapy (CRT) in mildly symptomatic heart failure patients, or those at risk of worsening heart failure, but not currently indicated under medical guidelines to receive treatment with the device.
“This study is important to guide therapy for heart failure patients with milder heart failure symptoms who have a dilated heart and poor heart function. These patients have a tendency to develop worsening symptoms, to require hospitalization, and they may die prematurely. This study will determine if cardiac resynchronization therapy, when used earlier in the disease, can delay or prevent the progression of heart failure,” said Anthony Tang, M.D., RAFT Nominated Principal Investigator and Adjunct Professor of Medicine, University of Ottawa.
CRT is a proven treatment for some patients with moderate to severe heart failure (New York Heart Association, or NYHA Class III and ambulatory Class IV) that improves the heart’s pumping efficiency, may help to reduce heart failure symptoms as well as hospitalizations and may improve quality of life and reduce mortality. The RAFT trial is one of several clinical trials underway to determine whether patients with mild or fewer symptoms (NYHA Class II) also may benefit from cardiac resynchronization therapy.
RAFT is a double-blinded, randomized, controlled trial led by the University of Ottawa Heart Institute and jointly supported by a peer-reviewed grant from Medtronic and the Canadian Institutes of Health Research (CIHR). It involves 1,800 patients with mild to moderate heart failure (NYHA Class II and III), left ventricular ejection fraction (LVEF, a measure of the heart’s pumping effectiveness) less than or equal to 30 percent and QRS duration of greater than or equal to 120 milliseconds. Patients in the control group received either a single or dual chamber ICD; patients in the “experimental” arm received a cardiac resynchronization therapy-defibrillator. The primary outcome is a composite of total mortality and heart failure hospitalization; secondary outcomes include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life, and cost economics. Patients will be followed for a minimum of 18 months.
Similar studies to RAFT, using CRT devices in this patient population, are being conducted in the U. S. The use of CRT devices is limited by federal law for this indication.
For more information: www.medtronic.com