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.

August 10, 2009
August 12, 2009
March 1, 2018
August 2009
October 2012   (Final data collection date for primary outcome measure)
  • Cardiovascular death or heart failure event [ Time Frame: Trial duration ]
  • Assess safety by evaluating all system or procedure-related complications [ Time Frame: Through six months post-implant ]
Same as current
Complete list of historical versions of study NCT00957073 on Archive Site
  • To assess the timing and frequency of primary efficacy endpoint events. [ Time Frame: 24 months post-randomization ]
  • To assess changes in Left Ventricular Mass Index [ Time Frame: 6 months post-randomization ]
  • To assess changes in quality of life [ Time Frame: 6 months post-randomization ]
Same as current
Not Provided
Not Provided
Rheos HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%) Trial
Health Outcomes Prospective Evaluation for Heart Failure With EF ≥ 40%
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.
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Failure
  • Device: Rheos Baroreflex Activation System
    Implant procedure
    Other Name: Rheos System
  • Other: Standard of care medical management
    Patients will continue with medical therapy for standard of care of their heart failure condition.
  • Experimental: Rheos Device
    Rheos Baroreflex Activation System
    Intervention: Device: Rheos Baroreflex Activation System
  • Active Comparator: Medical Management
    Medical Management Therapy
    Intervention: Other: Standard of care medical management
Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
April 2021
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
CVRx, Inc.
CVRx, Inc.
Not Provided
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
CVRx, Inc.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP