Research study tests new drug for prevention of atrial fibrillation in those with heart failure
Atrial fibrillation, or AF, is a very prevalent and growing heart rhythm disorder that increases the risk of stroke. AF combined with heart failure, where the pumping power of the heart is weaker than normal, is an especially tough combination of problems that significantly impairs a patient’s quality of life.
A new gene-directed drug being tested through a research study, called GENETIC-AF, may improve care, quality of life and survival in patients with heart failure and AF. Beaumont Health System is one of the study sites participating in the research. A previous study showed that the drug being evaluated, called bucindolol hydrochloride, reduced symptomatic atrial fibrillation when compared with placebo, a pill which contains no active ingredients, in patients with a specific gene variation, or genotype. In the current study, bucindolol, a betablocker, is being compared with another betablocker called metoprolol succinate, a heart failure drug approved by the Food and Drug Administration.
“This is an important study of personalized medicine,” says David Haines, M.D., director of Beaumont’s Heart Rhythm Center and the study’s principal investigator. “One of the challenges in the treatment of AF in patients with heart failure is that we sometimes need to try many different drugs in a trial and error fashion to find out what’s going to work. By doing genetic testing, we’ll be able to identify those patients who may get an optimal response to this new drug.”
About half of the U.S. population is believed to have the specific gene variation that responds to bucindolol in the suppression and prevention of AF.
Beaumont is first in Michigan to participate in this multicenter, national study which will ultimately involve about 200 patients at about 50 centers in the U.S. and Canada in its first phase. Dr. Haines serves on the steering committee overseeing the study’s design and results.
Patients who are candidates for the study will first receive genetic screening through a blood draw to determine if they have the genetic marker which has previously indicated a potential response to the drug. If they meet eligibility criteria, patients will be randomly assigned to one of two treatment groups to receive either the new study drug bucindolol or the drug metoprolol, which is approved for the treatment of heart failure but not for the prevention of atrial fibrillation. Study participation will last a minimum of six months, or up to four years.
“We’re hopeful that the Genetic-AF study is going to identify new strategies and new medications to improve quality of life and survival in patients with heart failure and AF,” says Dr. Haines.
According to the 2014 American Heart Association Report on Heart Disease and Stroke Statistics, the estimated number of people with AF in the U.S. in 2010 ranged from 2.7 to 6.1 million.
For more information on study participation, call Cardiology Research at 248-898-8141.
For information about GENETIC-AF, please visit ClinicalTrial.gov, a service of the U.S. National Institutes of Health.
Bucindolol hydrochloride, or Gencaro, the drug being evaluated in the study, is being developed by ARCA biopharma, a company dedicated to developing genetically-targeted therapies for cardiovascular diseases.
About Beaumont Heart & Vascular Care
Beaumont, Royal Oak is recognized among “America’s Best Hospitals” and as Michigan’s top-ranked hospital for cardiology and heart surgery by U.S. News & World Report for 2014-15. The Beaumont Heart and Vascular Center is a comprehensive, state-of-the-art facility that’s dedicated to the prevention, diagnosis and treatment of heart problems.Beaumont’s Ernst Cardiovascular Center offers a collaborative approach to treating and managing the most complex heart and vascular conditions, including atrial fibrillation, heart valve disease, heart failure, aortic aneurysm and dissection. The center also offers low-cost, preventive heart screening for adults and high school students. Beaumont’s Ministrelli Women’s Heart Center is the first in Michigan devoted exclusively to the prevention, diagnosis, and research of heart disease in women. Find out more at http://heart.beaumont.edu/.