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Rheos HOPE4HF Trial

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: October 29, 2012
Last verified: October 2012
History of Changes

August 10, 2009
October 29, 2012
August 2009
December 2013   (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 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.
Not Provided
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
  • Experimental: Rheos Device
    Rheos Baroreflex Activation System
    Intervention: Device: Rheos Baroreflex Activation System
  • No Intervention: Medical Management
    Medical Management Therapy
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. Epub 2010 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
540
December 2014
December 2013   (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 BNP or 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957073
360017-001
Yes
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.
October 2012

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