Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
current New York Heart Association (NYHA) Class III or
current NYHA Class II and historical NYHA Class III
Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) < 1600 pg/ml (should be within 3 months of screen)
Disqualifiers
Age < 18 years
Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
Bilateral carotid bifurcations located above the level of the mandible
Carotid artery stenosis greater than 50% caused by atherosclerosis
Trial design
Design model
Single group
Treatments tested in this trial
Baroreflex Activation Therapy
DeviceBarostim™ device (CVRx Inc.), a commercially available, FDA-approved device for autonomic modulation in HFrEF. The device system includes an implantable pulse generator, carotid sinus lead, and programmer system. No investigational modifications will be made. The device will be implanted per standard labeling and programming guidelines, and therapy titration will follow manufacturer recommendations.
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: Barostim™ TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in peak exercise PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Change from baseline will be calculated.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).Secondary outcomes
1
Change in peak exercise load-adjusted PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. PCWP measurements will be normalized to maximal exercise load at each time point. Change from baseline will be calculated.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).2
Change in peak exercise output-adjusted PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. PCWP measurements will be normalized to cardiac output at each time point. Change from baseline will be calculated.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).3
Change in peak exercise cardiac output at 6 months post-titration
Exercise cardiac output (CO) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise CO measured during the pre-implantation phase. Change from baseline will be calculated.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).4
Proportion of participants with significant reduction in PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Patients will be categorized into "responders" who demonstrate either a 10% reduction in PCWP or a 3 mmHg reduction in PCWP or "non-responders" who do not demonstrate at least this degree of percent or absolute change. The proportion of participants that are considered "responders" by this metric will be collected and assessed.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).Other outcomes
1
Correlate estimated peak VO2 by smartwatch to peak VO2 obtained via cardiopulmonary exercise testing
Participants' cardio fitness score (estimated peak VO2) will be compared for correlation to peak VO2 measurements obtained from cardiopulmonary exercise testing (CPET). The most recent cardio fitness score will be measured via study-provided Fitbit Inspire 3 fitness trackers to correspond temporally with the date of the CPET study. Correlations will be assessed separately at each time point, i.e., approximately six months post-Barostim titration and during the pre-implantation phase. Correlations will also be assessed using data from both time points.
Time frame
Pre-implantation phase (baseline, approx. 2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).2
Change in estimated peak VO2 by smartwatch after implantation over time
Participants' cardio fitness scores (estimated peak VO2) will be collected at regular intervals before and after implantation of the Barostim device. The cardio fitness scores will be measured via study-provided Fitbit Inspire 3 fitness trackers. These scores will be compared for trend over time.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-implantation phase (approximately 0-9 months post-implantation) at regular intervals, e.g., monthly3
Change in clinically significant echocardiography parameters at 6 months post-titration
Echocardiography will be obtained at approximately six months post-Barostim titration and compared with echocardiography measured during the pre-implantation phase. Measurements such as left and right atrial size; left and right ventricular size and systolic function; and presence and degree of aortic, mitral, tricuspid, and pulmonic stenosis or regurgitation will be compared. Change from baseline will be calculated.
Time frame
Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).4
Time to completion of Barostim device titration
Each participant's time to device titration will be obtained and summarized.
Time frame
Implantation and titration phases, to complete approximately 3 months after device implantation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
CVRx, Inc.
Collaborator
Source ClinicalTrials.gov