Medical Centers Enrolling Patients for the HOPE4HF Study:
List of Medical Centers in the United States:
- Cardiology Associates of Mobile, Inc., Mobile, AL
- Apex Cardiology Consultants, Inglewood, CA
- Florida Hospital Cardiovascular Institute, Orlando, FL
- Orlando Regional Medical Center, Orlando, FL
- Heart & Vascular Institute of Florida, St. Petersburg, FL
- Florida Cardiovascular Institute, Tampa, FL
- Iowa Heart Center, West Des Moines, IA
- The Care Group, Indianapolis, IN
- Forsyth Cardiovascular Research, Winston-Salem, NC
- University of Rochester, Rochester, NY
- The Lindner Clinical Trial Center, Cincinnati, OH
- Ohio State University Medical Center, Columbus, OH
- Northwest Ohio Cardiology Consultants/Jobst Vascular Center, Toledo, OH
- Oklahoma Cardiovascular Associates, Oklahoma City, OK
- Drexel University, Philadelphia, PA
- Allegheny General Hospital, Pittsburgh, PA
- Medical University of South Carolina, Charleston, SC
Study Goals
- To determine whether activating the baroreflex with the Rheos® System is a safe and effective treatment for heart failure patients.
- To determine whether the Rheos System can:
- Reduce heart failure symptoms
- Improve your heart function
- Help you live longer
- Improve your quality of life
- Reduce the number of hospital stays due to heart failure
Study Design
- Patients will be assigned to a treatment group by chance
- Two-thirds to Rheos® System plus medical management
- One-third to medical management alone
- Enrollment will be phased
- Phase 1: 100 patients will be enrolled at up to 25 sites
- Phase 2: 440 patients will be enrolled at up to 70 sites
- Study visits will occur at 1, 2, 3, 6, 9, 12, 15, and 18 months after patients are randomized to a treatment group
- Semi-annual visits will take place after 18 months and until the end of the study
Participant Requirements
- Keep all follow-up appointments.
- Tell your study doctor of any changes in your condition,
- Tell your study doctor about new medications or medical therapies that you or other doctors that you see may be considering for other health conditions.
