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BAROSTIM® Hope for Heart Failure Study (HOPE4HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01720160
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: BAROSTIM NEO® System Other: Standard of care medical managment therapy for heart failure Not Applicable

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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Barostim HOPE4HF Study
Study Start Date : November 2012
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Device
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.
Device: BAROSTIM NEO® System
Implant procedure
Other Name: Neo® System

Other: Standard of care medical managment therapy for heart failure
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.

Active Comparator: Medical Management
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.
Other: Standard of care medical managment therapy for heart failure
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.




Primary Outcome Measures :
  1. Heart failure metric improvements from baseline [ Time Frame: 12 months ]
    To describe changes in measures compared to baseline.

  2. System and procedure related adverse events [ Time Frame: 6 months ]
    To demonstrate the safety of the Neo system in a heart failure population.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• Treating physician decision that the subject should not continue with therapy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720160


Locations
Show Show 23 study locations
Sponsors and Collaborators
CVRx, Inc.
Investigators
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Study Chair: Michael Zile, MD Medical University of South Carolina
Principal Investigator: William Abraham, MD Ohio State University
Principal Investigator: Fred Weaver, MD University of Southern California
Principal Investigator: Faiez Zannad, MD Inserm Centre d'Investigation, CHU de Nancy
Principal Investigator: JoAnn Lindenfield, MD Vanderbilt Heart and Vascular Institute
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01720160    
Other Study ID Numbers: 360032-001
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by CVRx, Inc.:
Systolic Heart Failure
Congestive Heart Failure
Reduced left ventricular ejection fraction
HFrEF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases