Program in Experimental Cardiovascular Therapeutics
Why are Innovative New Drugs Needed for Acute Heart Failure?
Heart failure – the inability to supply adequate blood flow to meet the body’s need for oxygen and nutrients – has reached truly epidemic proportions. There are more than 1 million hospitalizations for heart failure in the United States every year, and similar numbers in Europe. Those numbers will continue to grow due to the fact that heart failure is age related and advances in heart care are successful in keeping patients alive after heart attacks that result in weakened heart muscle. The post-discharge mortality and rehospitalization rate can be as high as 15% and 30% respectively within 60-90 days, in spite of the implementation of evidence based therapies. It is important to emphasize that in spite of the successful implementation of federal performance measures in the United States, this event rate has not changed over the past decade. There is no other medical condition for which a patient becomes hospitalized, responds to therapy, and then has such a high event rate within such a short period of time. Importantly, none of the available therapies for chronic heart failure have been well tested in patients hospitalized with acute heart failure, and every single trial conducted to date with novel drug targets have been negative in terms of efficacy and/or safety.
How is the Center for Cardiovascular Innovation addressing this problem?
ART-HF. Given our wealth of experience in every aspect of drug development in heart failure and the availability of many new molecules for new drug development, Dr. Gheorghiade has spearheaded the creation of the international Acute Research Team – Heart Failure (ART-HF), comprised of leaders from centers of excellence across North America, Europe and Asia who have an enormous experience in drug development and the treatment of heart failure. We have already developed a collaborative strategy between preclinical pharmacology, clinical pharmacology, clinical development and ART-HF in which the main goal is to improve post-discharge outcomes by targeting the use of the new drugs to specific patient characteristics. A significant partnership has already been developed with the pharmaceutical industry, and we are now in the implementation phase.
Improve HF Bridge. Dr. Gheorghiade and colleagues are also in the process of implementing new strategies with proven, existing therapies in order to enhance post-discharge outcomes. One of the studies will be conducted in the near future at major medical centers in the United States and will evaluate measures to close the gap between what doctors know and what doctors actually do. This will develop systems of care to implement guidelines recommendations in the real world management of patients hospitalized for heart failure. This will include close coordination of physicians and nurses in the transition from inpatient to outpatient care, including a comprehensive assessment at a post-discharge outpatient visit within one week of hospital discharge.
Convening the International Stakeholders in Drug Development. Dr. Gheorghiade has brought together the world’s leading experts in developing and evaluating new drugs for heart failure, in order to identify new opportunities to design how promising new therapies should be tested and implemented. He chaired several meetings in which academic leaders and representatives of the Food and Drug Administration, the National Heart, Lung and Blood Institute, and the pharmaceutical industry identified common barriers to evaluating novel drugs in well-designed clinical trials and came to consensus that a new model for clinical trials is necessary. Dr. Gheorghiade has now been charged with creation of a new international Clinical Trial Initiative that will be an important cornerstone of the Center for Cardiovascular Innovation.