Clinical trial NCT02876042: BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction
Official title: BAROSTIM THERAPY ™ in Heart Failure With Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria.

Brief summary: The purpose of this registry (NCT02876042) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO system in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension that also have evidence of heart failure with preserved ejection fraction (HFpEF).

Detailed description: Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility Criteria:

The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include:

* Indications

  * Systolic blood pressure greater than or equal to 140 mmHg, and
  * Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications
* Contraindications

  * Bilateral carotid bifurcations located above the level of the mandible
  * Baroreflex failure or autonomic neuropathy
  * Uncontrolled, symptomatic cardiac bradyarrhythmias
  * Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
  * Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Eligibility criteria: Inclusion Criteria:

* Sign an Ethics Committee (EC) approved informed consent form for the registry.
* Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment.
* BAROSTIM THERAPY not yet chronically activated.
* Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant.
* On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment.
* Objective evidence of heart failure according to the following criteria:

  * Hospitalization for heart failure within 12 months prior to enrollment OR
  * Echocardiographic evidence of diastolic dysfunction (LA Volume Index \>34 ml/m2 OR E/e \>13) within 30 days prior to enrollment OR
  * NTproBNP \> 220 pg/mL or BNP \> 80 pg/mL (in atrial fibrillation, NTproBNP \> 600 pg/mL or BNP \> 200 pg/mL) within 30 days prior to enrollment

Exclusion Criteria:

* Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
* Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.

Primary outcomes:
measure: Changes in Office Cuff Systolic Blood Pressure
timeFrame: Pre-implant baseline to 6 months post-implant
Secondary outcomes:
measure: Change in New York Heart Association Functional Classification
timeFrame: Pre-implant baseline to 6 months post-implant
measure: Changes in Left Ventricular Mass Index
timeFrame: Pre-implant baseline to 6 months post-implant
measure: Changes in LA volume index
timeFrame: Pre-implant baseline to 6 months post-implant
measure: Changes in E/E' ratio
timeFrame: Pre-implant baseline to 6 months post-implant
measure: Changes in NT-proBNP
timeFrame: Pre-implant baseline, 6 months post-implant
measure: Evaluate health care utilization over follow-up, such as heart failure hospitalizations
timeFrame: Pre-implant baseline to 6 months post-implant
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berlin Charité & Deutschen Herzzentrum Berlin
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Detmold
country: Germany
facility: Lippe Klinikum
city: Frankfurt
country: Germany
facility: Uniklinik Frankfurt
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Göttingen
country: Germany
facility: Herzzentrum Göttingen
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg
city: Ingolstadt
country: Germany
facility: Kardiologie im Klinikum Ingolstadt
city: Köln
country: Germany
facility: Universitätsklinikum Köln Herzzentrum
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Siegen
country: Germany
facility: Marienkrankenhaus Siegen
Study officials:
affiliation: Universitätmedizin Berlin - Charité
name: Burkert Pieske, PhD
role: STUDY_CHAIR
References:
citation: 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.