CHICAGO --- Over 5 million people in the United States are affected with chronic heart failure (CHF), a condition that results in approximately 1 million hospitalizations annually. Hospitalization usually is associated with a poor prognosis, high hospital readmission rates and death within 30 to 60 days after discharge.
In this patient population, placebo-control, randomized clinical studies, the "gold standard of medicine" from which evidence-based management guidelines normally are derived, are lacking, says heart failure expert Mihai Gheorghiade, M.D., professor of medicine and vice-chief of cardiology at The Feinberg School of Medicine and Northwestern Memorial Hospital.
By contrast, there are many placebo-controlled, randomized clinical studies for other conditions that normally result in hospitalization, namely, acute myocardial infarction (MI), or heart attack.
"When compared to MI, CHF is just as devastating for patients, but there hasnt been nearly the number of large clinical trials," said Duke cardiologist Michael Cuffe, M.D. "The problem is that these trials are very difficult to conduct, and thats what makes this study so important."
Gheorghiade and Cuffe, with co-researchers from Duke University and other medical centers, conducted the first large placebo-controlled, randomized trials of existing therapies for exacerbation of chronic CHF in order to help develop treatment guidelines for this condition.
Results of one of these studies, on the use of milrinone, an intravenous drug administered to increase heart muscle contractility and approved by the FDA to treat worsening CHF, were published in the March 27 issue of the Journal of the American Medical Association.
Results of the other studies, which are investigating the use of beta-blockers, new diuretics or other drugs, are forthcoming from the same group of researchers.