Evaluation of Sympathetic Activity Effects by the BackBeat Medical Cardiac Neuromodulation Therapy (CNT).

NCT05462405 | Active Not Recruiting DMC

• 1 other identifier: CS-09 BBM MSNA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, will be applied to subjects who have been already implanted with a Moderato IPG delivering the BackBeat CNT and/or pacing signals. Several tests will be performed by experienced professionals to ensure the acquired sympathetic nerve signals arise from the targeted nerve source. The Moderato Programmer will be then used to program different sets of CNT for several minutes with a several minutes interval between delivery periods. This delivery pattern is used will allow to acquire sympathetic nerve signals with and without CNT. Subject blood pressure, respiration and ECG data will be collected and recorded, both for safety and for evaluation of CNT dependent secondary indicators of sympathetic activity.

Conditions

Hypertension

Keywords

Moderato implant

Outcome Measures

Primary Outcomes (1)

• Sympathetic activity will be calculated as burst frequency (bursts/min) and as burst incidence (bursts/100 heartbeats). A change in the nerve activity occurring between pacing and CNT is expected.

  Nerve firing is organised in burst activity which can be detected by the data acquisition system

  through study completion (18 months)

Secondary Outcomes (1)

• A change in Systolic Blood Pressure

  through study completion (18 months)

Study Arms (1)

Experimental group

EXPERIMENTAL

All subjects enrolled will be in the same experimental group.

Procedure: Experimental group

Interventions

Experimental group PROCEDURE

In the setting phase subjects will be in recumbent position. A microneurography needle (0.2mm diameter isolated Tungsten micro-electrode) will be placed under the skin. An identical (not isolated) reference needle tip will be inserted within 2 cm of the first electrode. These are connected to a recording system (ADInstruments PowerLab). Once sympathetic activity can be measured using the needles, a sympathetic specific test will be used to calibrate the measurement and recording system. In the testing phase sequential pacing and CNT delivery will be programmed for a few minutes, the whole procedure expected to last less than 2 hours.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is already implanted with a Moderato IPG that can be used to deliver CNT pacing signals, whether CNT pacing was activated or not.
• Subject is willing and able to comply with the study and procedures.

You may not qualify if:

• Subject is dependent on 100% ventricular pacing.
• Subject has symptoms of heart failure, NYHA Class III or greater.
• Subject has an ejection fraction of 25% or less
• Subject's systolic blood pressure is less than 100 mm Hg on the day of recording.
• Subject has decompensated heart failure
• Subject has significant (\>3+) mitral regurgitation, aortic regurgitation, or aortic stenosis
• Subject has permanent atrial fibrillation.
• Subject has Atrial fibrillation on the day of the study.
• Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm.
• Subject is on dialysis
• Subject has prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit.
• Subject has a history of autonomic dysfunction.
• Women who are pregnant or breast-feeding.
• Subject cannot or is unwilling to provide informed consent

Sponsors & Collaborators

• BackBeat Medical Inc: lead

Study Sites (1)

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (3)

• Heusser K, Tank J, Engeli S, Diedrich A, Menne J, Eckert S, Peters T, Sweep FC, Haller H, Pichlmaier AM, Luft FC, Jordan J. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. 2010 Mar;55(3):619-26. doi: 10.1161/HYPERTENSIONAHA.109.140665. Epub 2010 Jan 25.

  PMID: 20101001 RESULT

• 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.

  PMID: 21300307 RESULT

• Hering D, Lambert EA, Marusic P, Walton AS, Krum H, Lambert GW, Esler MD, Schlaich MP. Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension. Hypertension. 2013 Feb;61(2):457-64. doi: 10.1161/HYPERTENSIONAHA.111.00194. Epub 2012 Nov 19.

  PMID: 23172929 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bela Merkely, D, Ph.D.

  Heart and vascular Centre, Semmelweiss University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Indirect evidence \[see reference 1\] shows that CNT may decrease the level of sympathetic activity locally (in the heart) and systemically. However, this effect was never directly measured in an experiment. It is also theorized that the decrease of sympathetic activity may persist for some time after CNT delivery is stopped, but this has to be verified using direct sympathetic activity level measurement. Such direct evidence of sympathetic activity reduction may enable application of CNT therapy to other diseases and patients that do not have adequate therapies today, such as heart failure.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: December 10, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

HU (1)