News | December 23, 2009

Beta-Blocker May be Tested to Treat Heart Failure

December 23, 2009 – An investigational beta-blocker drug may be tested to see if it helps slow the progression of chronic heart failure in patients who have a specific genotype.

ARCA biopharma Inc. said this week it submitted a study protocol for review under the FDA’s special protocol assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of the drug Gencaro. The trial would include about 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.

The drug is a beta-blocker and mild vasodilator. The FDA has previously designated the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population as a fast-track development program. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval.

The proposed trial protocol includes a superiority comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. The proposed trial protocol also includes an interim data analysis at a prespecified number of primary endpoints. If the proposed protocol and criteria are agreed to by the FDA, the company anticipates the proposed trial could reach the specified number of endpoint events as soon as two years after the trial begins. The SPA submission proposes a composite of cardiovascular mortality and cardiovascular hospitalization serve as the primary endpoint of the trial.

Subject to the timing and outcome of the FDA’s review of the SPA submission, and subject to the Company’s ability to obtain sufficient funding, the company currently expects it could begin the proposed trial in late 2010 or the first half of 2011.

For more information: www.arcabiopharma.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init