Heart FailureHOPE4HFNCT01720160
BAROSTIM® Hope for Heart Failure Study
A study testing BAROSTIM NEO® System in people with Heart Failure, run by CVRx, Inc. at 23 sites in United States.
Trial summary
The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160). 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?
- BAROSTIM NEO® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2012to Mar 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
- Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON.
- Have signed a revised approved informed consent form for continued participation in this study.
Who cannot join
- Treating physician decision that the subject should not continue with therapy.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Lonestar Heart Center
Amarillo, Texas, 79106
Piedmont Heart Institute
Atlanta, Georgia, 30309
ACRC - Cardiology
Atlantis, Florida, 33462
St Elizabeth's Medical Center
Brighton, Massachusetts, 02135
The Ohio State University
Columbus, Ohio, 43210
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiovascular Institute of the South
Houma, Louisiana, 70360
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
University of Southern California
Los Angeles, California, 90033
Southwest Cardiovascular Associates
Mesa, Arizona, 85206
Mid-Michigan Medical Center Midland
Midland, Michigan, 48670
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, 53215
Advocate Medical Group
Naperville, Illinois, 60540
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
AdventHealth Orlando
Orlando, Florida, 32803
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Arizona Heart Rhythm Research Center
Phoenix, Arizona, 53226
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Tampa General Hospital
Tampa, Florida, 33606
George Washington University
Washington D.C., District of Columbia, 20037
Aspirus Heart & Vascular Institute
Wausau, Wisconsin, 55401
About this study
Official title: Barostim HOPE4HF Study
The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).
Read the detailed description
A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.
- Conditions
- Heart Failure
- Being tested
- BAROSTIM NEO® System, Standard of care medical managment therapy for heart failure
- Keywords
- Systolic Heart Failure, Congestive Heart Failure, Reduced left ventricular ejection fraction, HFrEF
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAROSTIM NEO® SystemDevice
Also called Neo® System
Implant procedure
Standard of care medical managment therapy for heart failureOther
Standard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | 1) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. Receives: Device: BAROSTIM NEO® System; Other: Standard of care medical managment therapy for heart failure |
| Medical Management | Active comparator | Standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. Receives: Other: Standard of care medical managment therapy for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure metric improvements from baseline
To describe changes in measures compared to baseline.
Measured: 12 months
System and procedure related adverse events
To demonstrate the safety of the Neo system in a heart failure population.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2015
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zile, MD, Study chair, Medical University of South CarolinaWilliam Abraham, MD, Principal investigator, Ohio State UniversityFred Weaver, MD, Principal investigator, University of Southern CaliforniaFaiez 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
- NCT01720160
- Sponsor's protocol ID
- 360032-001
- Acronym
- HOPE4HF
- Status last verified
- May 2019
- First submitted
- 29 Oct 2012
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
PubMed 25982108Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.
PubMed 29705650Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
PubMed 26011593
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barostim HOPE4HF Study
- ClinicalTrials.gov ID
- NCT01720160
- Acronym / sponsor ID
- HOPE4HF / 360032-001
- Conditions
- Heart Failure
- Keywords
- Systolic Heart Failure, Congestive Heart Failure, Reduced left ventricular ejection fraction, HFrEF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 2 Nov 2012 (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 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).
Detailed description
A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.
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: BAROSTIM NEO® System, Other: Standard of care medical managment therapy for heart failure1) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. |
| Medical Management | Active comparator | Other: Standard of care medical managment therapy for heart failureStandard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON.
- Have signed a revised approved informed consent form for continued participation in this study.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| BAROSTIM NEO® SystemAlso: Neo® SystemImplant procedure | Device | Device |
| Standard of care medical managment therapy for heart failureStandard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. | Other | Device, Medical Management |
Primary outcome
Heart failure metric improvements from baseline
Time frame: 12 months
To describe changes in measures compared to baseline.
System and procedure related adverse events
Time frame: 6 months
To demonstrate the safety of the Neo system in a heart failure population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Results publication: PubMed 25982108Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
- Derived from this study: PubMed 29705650Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.
- Derived from this study: PubMed 26011593Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
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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.
Michael Zile, MD study chair
Medical University of South Carolina
William Abraham, MD principal investigator
Ohio State University
Fred Weaver, MD principal investigator
University of Southern California
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAROSTIM NEO® System in people with Heart Failure, run by CVRx, Inc. at 23 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: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Results are not available in the source record.
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?
Heart failure metric improvements from baseline (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01720160, which also lists 3 linked publications.
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 14 May 2019.