Trial record 1 of 1 for:    NCT00957073
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Rheos HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%) Trial (HOPE4HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957073
Recruitment Status : Active, not recruiting
First Posted : August 12, 2009
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of the HOPE4HF trial is to demonstrate the safety and efficacy of the Rheos Baroreflex Activation Therapy System in subjects with heart failure with an EF ≥ 40% in a prospective, randomized trial.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Rheos Baroreflex Activation System Other: Standard of care medical management Phase 2 Phase 3

Detailed Description:
This study closed to enrollment before adequate endpoint data was collected and before enrollment was completed. The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device. Currently, subjects are still enrolled in the trial under long-term follow-up.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Outcomes Prospective Evaluation for Heart Failure With EF ≥ 40%
Study Start Date : August 2009
Actual Primary Completion Date : October 2012
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Rheos Device
Rheos Baroreflex Activation System
Device: Rheos Baroreflex Activation System
Implant procedure
Other Name: Rheos System

Active Comparator: Medical Management
Medical Management Therapy
Other: Standard of care medical management
Patients will continue with medical therapy for standard of care of their heart failure condition.

Primary Outcome Measures :
  1. Cardiovascular death or heart failure event [ Time Frame: Trial duration ]
  2. Assess safety by evaluating all system or procedure-related complications [ Time Frame: Through six months post-implant ]

Secondary Outcome Measures :
  1. To assess the timing and frequency of primary efficacy endpoint events. [ Time Frame: 24 months post-randomization ]
  2. To assess changes in Left Ventricular Mass Index [ Time Frame: 6 months post-randomization ]
  3. To assess changes in quality of life [ Time Frame: 6 months post-randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 21 years of age
  • Have bilateral carotid bifurcations that are below the level of the mandible
  • Have a left ventricular ejection fraction ≥ 40%
  • Symptomatic heart failure with elevated blood pressure
  • Elevated brain natriuretic peptide (BNP) or n-terminal pro-brain natriuretic peptide (NT-proBNP)
  • Serum creatine ≤ 2.5 mg/dL and not being treated with dialysis

Exclusion Criteria:

  • Known or suspected baroreflex failure or autonomic neuropathy
  • History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, or primary hypertrophic cardiomyopathy
  • Solid organ or hematologic transplant
  • History of prior surgery, radiation, or stent placement in carotid sinus region
  • Life expectancy of less than one year for non-cardiovascular reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957073

United States, Alabama
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States, 36608
United States, California
Apex Cardiology Consultants
Inglewood, California, United States, 90301
University of Southern California
Los Angeles, California, United States, 90033
United States, Connecticut
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
Florida Hospital Cardiovascular Institute/Florida Heart Group
Orlando, Florida, United States, 32803
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Heart and Vascular Institute of Florida
Saint Petersburg, Florida, United States, 33709
Florida Cardiovascular Institute
Tampa, Florida, United States, 33609
United States, Indiana
The Care Group
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Missouri
Liberty Cardiovascular Specialists
Liberty, Missouri, United States, 64068
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Forsyth Cardiovascular Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Lindner Research Center
Cincinnati, Ohio, United States, 45219
Ohio State University
Columbus, Ohio, United States, 43210
Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States, 43615
United States, Oklahoma
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
CVRx, Inc.
Principal Investigator: William Abraham, MD Ohio State University
Principal Investigator: William Little, MD Wake Forest University
Principal Investigator: Fred Weaver, MD University of Southern California
Principal Investigator: Michael Zile, MD Medical University of South Carolina

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CVRx, Inc. Identifier: NCT00957073     History of Changes
Other Study ID Numbers: 360017-001
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by CVRx, Inc.:
Heart Failure
Diastolic dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases