Heart FailureHOPE4HFNCT00957073
Rheos System for the Treatment of HFpEF Heart Failure
A study testing Rheos® system in people with Heart Failure, run by CVRx, Inc. at 22 sites in United States.
Trial summary
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Rheos® system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2009to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently implanted with the Rheos device and actively participating in the HOPE4HF Trial (G090001).
- Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study.
Who cannot join
- 1. Treating physician decision that the subject should not continue with therapy.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Lindner Research Center
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43210
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Cardiovascular Institute of the South
Houma, Louisiana, 70360
The Care Group
Indianapolis, Indiana, 46260
Apex Cardiology Consultants
Inglewood, California, 90301
Liberty Cardiovascular Specialists
Liberty, Missouri, 64068
University of Southern California
Los Angeles, California, 90033
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, 36608
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Florida Hospital Cardiovascular Institute/Florida Heart Group
Orlando, Florida, 32803
Orlando Regional Medical Center
Orlando, Florida, 32806
Drexel University
Philadelphia, Pennsylvania, 19102
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Rochester Medical Center
Rochester, New York, 14642
Washington University
St Louis, Missouri, 63110
Heart and Vascular Institute of Florida
St. Petersburg, Florida, 33709
Florida Cardiovascular Institute
Tampa, Florida, 33609
Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615
Iowa Heart Center
West Des Moines, Iowa, 50266
Forsyth Cardiovascular Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.
Read the detailed description
The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure.
The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.
- Conditions
- Heart Failure
- Being tested
- Rheos® system
- Keywords
- Heart Failure, Diastolic dysfunction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheos® systemDevice
Also called Rheos® Baroreflex Activation Therapy®, Neo Legacy® System, BAROSTIM NEO® LEGACY System
Implant procedure
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Rheos® system Receives: Device: Rheos® system |
| Medical Management | No intervention | Medical Management Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To ascertain long-term adverse events for subjects implanted with the device.
To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device.
Measured: Trial duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2012
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Abraham, MD, Principal investigator, Ohio State UniversityFred Weaver, MD, Principal investigator, University of Southern CaliforniaMichael Zile, MD, Study chair, Medical University of South CarolinaFaiez Zannad, MD, Principal investigator, Inserm Centre d'Investigation, CHU de NancyJoAnn Lindenfield, MD, Principal investigator, Vanderbilt Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957073
- Sponsor's protocol ID
- 360017-001
- Acronym
- HOPE4HF
- Status last verified
- Apr 2021
- First submitted
- 10 Aug 2009
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 21300307
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%
- ClinicalTrials.gov ID
- NCT00957073
- Acronym / sponsor ID
- HOPE4HF / 360017-001
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Diastolic dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.
Detailed description
The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure.
The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Rheos® systemRheos® system |
| Medical Management | No intervention | –Medical Management Therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently implanted with the Rheos device and actively participating in the HOPE4HF Trial (G090001).
- Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study.
Key exclusion criteria (1 listed)
- 1. Treating physician decision that the subject should not continue with therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheos® systemAlso: Rheos® Baroreflex Activation Therapy®, Neo Legacy® System, BAROSTIM NEO® LEGACY SystemImplant procedure | Device | Device |
Primary outcome
To ascertain long-term adverse events for subjects implanted with the device.
Time frame: Trial duration
To systematically and actively ascertain the type, frequency, severity and timing of long-term adverse events in subjects implanted with the device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 21300307Georgakopoulos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Abraham, MD principal investigator
Ohio State University
Fred Weaver, MD principal investigator
University of Southern California
Michael Zile, MD study chair
Medical University of South Carolina
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheos® system in people with Heart Failure, run by CVRx, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To ascertain long-term adverse events for subjects implanted with the device. (time frame: Trial duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.