Rheos HOPE4HF Trial - Full Text View

Purpose

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	Intervention	Phase
Heart Failure	Device: Rheos Baroreflex Activation System	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Health Outcomes Prospective Evaluation for Heart Failure With EF ≥ 40%

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	540
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rheos Device Rheos Baroreflex Activation System	Device: Rheos Baroreflex Activation System Implant procedure Other Name: Rheos System
No Intervention: Medical Management Medical Management Therapy

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957073

Locations

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
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Florida Hospital Cardiovascular Institute/Florida Heart Group
Orlando, Florida, United States, 32803
Heart and Vascular Institute of Florida
St. 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
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14618
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.

Investigators

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

More Information

No publications provided by CVRx, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT00957073 History of Changes
Other Study ID Numbers:	360017-001
Study First Received:	August 10, 2009
Last Updated:	October 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by CVRx, Inc.:

Heart Failure
Diastolic dysfunction

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013