Clinical Research: Investigating medication interference with heart failure, cardiac rhythm disorders

Clinical trials, the study of medical treatment in humans, are performed to determine the safety and effectiveness of a specific treatment, which can include drugs, devices and techniques. Investigating various treatments allows doctors to determine methods to improve healthcare and find betters means of preventing, diagnosing and treating diseases.

At Health Quest, cardiology clinical trials are one of four specialty areas dedicated to clinical research, including cancer, neurology and colorectal trials.

Together with The Heart Center, the Division of Clinical Research has recently initiated three distinct clinical trials: Augustus CV 185-317, Paradise MI and Pioneer HF. Although each trial involves different variables, each examines the effect of specific medications on heart failure and cardiac rhythm disorders.

Augustus CV 185-316 is a study of cardiac rhythm disorders, or an irregular heartbeat. The primary focus of this study is to compare the safety and bleeding risk among participants taking two separate drugs, Apixaban and the Vitamin K Antagonist, Warfarin, when taken for six months by patients with atrial fibrillation (an irregular heartbeat), a recent heart attack or a recent procedure to open a blood vessel in the heart.

More specifically, this study examines the cardio and cerebrovascular outcomes of patients managed with Apixaban, versus Warfarin, both with or without aspirin. All participants are also required to take the blood-clotting drug Plavix as part of this six month study-period. Both drugs in this study are commonly used to reduce the risk of stroke in individuals with atrial fibrillation, an irregular heartbeat.

Paradise MI is a Phase III trial which investigates the effectiveness and safety of Valsartan combined with Sacubitril versus Ramipril alone for heart failure. Valsartan is used to treat high blood pressure, congestive heart failure and has been demonstrated to increase one's survival rate following a heart attack, while Ramipril is used to treat high blood pressure as prevention against strokes and heart attacks.

This trial assesses the study treatment by comparing it with the current standard of care for heart failure. After a successful Phase III trial, a treatment is then eligible to be marketed to the public following a formal review by the FDA.

Pioneer HF examines two heart failure medications to assess the impact of in-hospital introductions to Valsartan and Enalapril, both used to treat high blood pressure and heart failure, on a major predictive protein for disease progression in patients who have been stabilized following hospitalization for sudden or worsening symptoms of heart failure, acute decompensated heart failure and reduced ejection fraction, the amount of blood pumped from the heart with each heartbeat.

As a Phase IV study, this treatment is available to the general public. However, post-marketing observation is in progress to further study any interactions it may have with other treatments and to further assess the long-term safety and effectiveness of the treatment.

At this time, the Division of Clinical Research has 25 ongoing clinical trials, with 3 new trials opening this month.

Dr. Ernest Roos is the director of the Health Quest Division of Clinical Research.  To learn more about clinical research and find out if you are eligible to participate in a clinical research trial, contact the Division of Clinical Research at 845-483-6825 (TTY: 800-421-1220), or visit healthquest.org/clinicalresearch.