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New Trial Investigates Heart Failure Prevention
Heart failure (HF) is a major unresolved public health problem in the United States. Cardiologists diagnose about 500,000 new cases each year, and a reservoir of about five million patients with HF exists at any given time. It is the leading cause of hospitalization in the U.S, and is the most rapidly growing cardiovascular disorder.
While clinical research has identified, and helped to dramatically enhance, treatment options for HF patients, how to prevent HF, or significantly prolong its onset, is the focus of Guidant Corporation’s newest trial MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy). Like MADIT and MADIT II, the MADIT-CRT trial is exclusively sponsored by Guidant under the leadership of principal investigator Dr. Arthur J. Moss, professor of medicine at the University of Rochester.
The trial, taking place at 15 medical centers in Canada and Europe, as well as 78 medical centers in the U.S., including Deborah Heart and Lung Center, is comparing the use of an implantable defibrillator that stimulates the right and left sides of the heart simultaneously to improve the efficiency of contraction (Biventricular ICD) to the conventional dual chamber defibrillator. Doctors hope to enroll 1,800 patients nationwide, and Raffaele Corbisiero, MD, Director, Section of Electrophysiology at Deborah expects at least 20 to 30 of those patients to come from Deborah.
Biventricular ICD therapy has been shown, in prior clinical trials, to improve survival in patients with more advanced forms of HF, compared to the best conventional therapy. By examining the use of cardiac resynchronization therapy defibrillators (CRT-D) in heart attack survivors with impaired cardiac function, MADIT-CRT researchers aim to determine if the Biventricular ICD can improve survival and quality of life in patients with milder forms of HF, and/or slow or halt the progression of the disease in high risk populations.
“While major advancements have been made in the treatment of heart failure, we are still uncertain as to whether prophylactic CRT in combination with an implantable cardioverter defibrillator can inhibit or slow the development of symptomatic HF and reduce all-cause mortality,” said Dr. Corbisiero, Deborah’s MADIT-CRT principle investigator. “The Trial’s aim is to determine if earlier intervention with CRT-D therapy can slow a patient’s progression from early stage heart failure to late stage heart failure.”
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Study Design
MADIT-CRT is a randomized, three to five year trial comparison of patients receiving either CRT and ICD (CRT-D), or ICD alone. Qualifying patients must have NYHA class I or II heart failure, with an ejection fraction and 30 percent. Potential subjects are screened for eligibility in the hospital or outpatient setting by the study coordinator, and if a patient is deemed a good candidate, approval is obtained from the patient’s primary care physician, who is then asked to contact the patient for potential participation.
“These patients are on minimal medications, their breathing is normal, and they are not experiencing heart failure, but make no mistake, they are facing very real dangers,” said Dr. Corbisiero. “Not only are these patients at risk for sudden cardiac death, they are also at risk for developing heart failure,” continued Dr. Corbisiero. “What’s great about this study is that the eligible candidates are in need of a device anyway. Asking them to participate in a study that may also help prevent or prolong heart failure down the line is a win-win.”
Follow Up
All subjects randomized in the study will be followed at regular intervals with clinic visits and phone contact by MADIT-CRT professional staff in conjunction with their primary care physician. The study follow-up visits include device interrogation, assessment of quality of life, and cardiac status. The 12-month visit includes a blood draw to measure BNP, a Holter recording (CRT-D only), a six-minute walk test, and an echocardiogram.
“Heart failure is the number one disease in this country,” said Dr. Corbisiero. “It’s also the number one DRG, the number one discharge diagnosis, the number one Medicare cost, and it kills more people than lung cancer, breast cancer and AIDS combined. If we can find a way to prevent or delay its onset, we’ve really accomplished something.”
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