News | September 15, 2014

Beaumont First in Michigan to Test Gene-Directed Prevention Treatment for AFib

Research study to test new drug for prevention of atrial fibrillation in those with heart failure

September 15, 2014 — 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 atrial fibrillation (AF). The Beaumont Health System in metropolitan Detroit is one of the study sites participating in the research. A previous study showed the drug being evaluated, called bucindolol hydrochloride, reduced symptomatic AF when compared with placebo 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 U.S. Food and Drug Administration (FDA).

“This is an important study of personalized medicine,” said 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 national multicenter study, which will ultimately involve about 200 patients at about 50 centers in the United States and Canada in its first phase. 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,” said Haines.

For more information: http://clinicaltrials.gov/ct2/show/NCT01970501

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