Baroreflex Activation Therapy for Heart Failure (BeAT-HF)
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|ClinicalTrials.gov Identifier: NCT02627196|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2015
Last Update Posted : December 17, 2020
The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).
The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: BAROSTIM NEO® System Drug: Medical Management||Not Applicable|
The BAROSTIM NEO - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure. Subjects will be randomized in a 1:1 ratio to receive Barostim Activation Therapy with an implanted BAROSTIM NEO System in addition to medical management or to receive medical management alone (no device implant). The trial will be conducted at up to 120 investigational centers in the U.S. and up to 20 investigational centers outside the U.S. These centers will enroll up to 1200 subjects to randomize approximately 480 subjects who meet the entry criteria.
For all subjects, trial visits will occur at 0.5, 1, 1.5, 2, 3, 6, 9 and 12 months post-implant (post anticipated implant for medical management). Visits will occur quarterly from 15 to 24 months and semi-annually thereafter.
Subjects are followed in an identical manner regardless of trial arm.
The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence of morbidity and mortality benefit. This trial will involve one or more interim analyses to evaluate when sufficient evidence is reached for the final morbidity and mortality analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure|
|Actual Study Start Date :||April 19, 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Device and Medical Management
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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
Drug: Medical Management
Active Comparator: Medical Management
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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.
Drug: Medical Management
- Rate of Cardiovascular Mortality and Heart Failure Morbidity [ Time Frame: At study completion, approximately 5 years ]To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant.
- Major Adverse Neurological and Cardiovascular Events (MANCE) [ Time Frame: 6 months post implant ]To demonstrate the safety of the Barostim NEO® System via the event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 6 months post implant in the device arm.
- Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) [ Time Frame: 6 months post implant ]To demonstrate that treatment with the BAROSTIM NEO® system results in a larger reduction in NT-proBNP at 6 months than medical management.
- Six Minute Hall Walk (6MHW) [ Time Frame: 6 months post implant. ]To demonstrate that treatment with the BAROSTIM NEO® system results in a larger improvement in 6MHW at 6 months than medical management
- Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) [ Time Frame: 6 months post implant ]To demonstrate that treatment with the BAROSTIM NEO® System results in a larger improvement in MLWHF QOL at 6 months than medical management
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): NCT02627196
|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|