Rheos HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%) Trial (HOP4HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00957073
First received: August 10, 2009
Last updated: June 1, 2016
Last verified: June 2016

August 10, 2009
June 1, 2016
August 2009
October 2012   (final data collection date for primary outcome measure)
  • Cardiovascular death or heart failure event [ Time Frame: Trial duration ] [ Designated as safety issue: Yes ]
  • Assess safety by evaluating all system or procedure-related complications [ Time Frame: Through six months post-implant ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00957073 on ClinicalTrials.gov Archive Site
  • To assess the timing and frequency of primary efficacy endpoint events. [ Time Frame: 24 months post-randomization ] [ Designated as safety issue: Yes ]
  • To assess changes in Left Ventricular Mass Index [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
  • To assess changes in quality of life [ Time Frame: 6 months post-randomization ] [ Designated as safety issue: No ]
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19
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
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957073
360017-001
Yes
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.
June 2016

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