Cardiac Neuromodulation Therapy (CNT) "Washout" Sub-Study

November 2, 2022 updated by: BackBeat Medical Inc

Addendum to Protocol CS-03: Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445

This washout protocol is structured as a sub-study for patients willing to participate after finishing the double blind randomised phase of the clinical trial, NCT02837445. Devices will be turned off for a week approximately. Patients will have their PHC programmed to automatically turn off 24 hr after a medical and technical visit and remain in regular pacing. Ambulatory recording of the BP will start at the end of the visit, and continue for 24 hr after the turn off time (48 hr recording). Conversely, patients will return at the end of the first week, when a second 48 hr recording will be initiated, this time, the PHC will be programmed to turn on 24 hr later. The recordings therefore will provide data of the ON to OFF transition for the evaluation of the residual effect of PHC after 24 h and after week.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As detailed in protocol CS-03, the BackBeat Moderato system applies standard pacing signals according to a specially timed, alternating sequence short and longer atrioventricular (AV) delays, to reduce blood pressure as a treatment for hypertension. The algorithm that governs the delivery of these pacing signals is referred to as Cardiac Neuromodulation Therapy (CNT) and the signals are referred to as Programable Hypertension Control (PHC) signals, (refer to Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445) As currently used, CNT requires continuous right ventricle (RV) pacing. However, due to potentially long-term effects of CNT on baroceptor function, intermittent deactivation of CNT could reduce the overall amount of pacing without loss of efficacy. Support for this hypothesis comes from a preclinical testing of CNT that was detailed in "Chapter II - Pre-Clinical Testing" of the approved Investigator Brochure. BackBeat Medical conducted a chronic feasibility study in 4 dogs with hypertension induced by renal artery banding which were implanted with a Moderato IPG for 4 months. Results from this study showed that when CNT was turned off after 30 days of continuous CNT, there was a very slow increase in systolic pressure, approaching pre-therapy levels only several weeks later. A 50% residual effect remained at 20 days, with a total washout period of approximately 30 days.

One possible explanation for this observation is that the signal beneficially changes the pressure"set point" of the baroceptor reflexes. Changes in the set point could result from changes at the level of either the pressure sensor in the carotid sinus or within the pressure regulatory region of the central nervous system; namely the nucleus tractus solitarius (NTS) in the medulla oblongata.

This sub-study aims to evaluate whether and for how long the blood-pressure lowering effect of CNT persists following its cessation in patients who have been treated with CNT for a prolonged period of time.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia, 15030
        • Completed
        • Na Homolce Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Completed
        • Semmelweis University Heart and Vascular Center
  • Poland
      • Poznań, Poland, 61-848
        • Not yet recruiting
        • Szpital Kliniczny Przemiemienia Panskiego
        • Contact:
        • Principal Investigator:
          • Przemyslaw Mitkowski, Prof.
        • Sub-Investigator:
          • Tomasz Smukowski, Dr.
        • Sub-Investigator:
          • Lidia Chmielewska-Michalak, Dr.
        • Sub-Investigator:
          • Michal Wasniewski, Dr.
        • Sub-Investigator:
          • Wojciech Seniuk, Dr.
        • Sub-Investigator:
          • Agnieszka Katarzyńska-Szymanska, Dr.
      • Szczecin, Poland, 70-111
        • Not yet recruiting
        • Pomeranian Medical University Hospital no. 2
        • Contact:
        • Principal Investigator:
          • Jaroslaw Kazmierczak, Prof.
        • Sub-Investigator:
          • Radoslaw Kiedrowicz, Dr.
        • Sub-Investigator:
          • Marcin Zakrzewski, Dr.
        • Sub-Investigator:
          • Maciej Wielusinski, Dr.
      • Warsaw, Poland, 02-097
        • Not yet recruiting
        • Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
        • Contact:
        • Principal Investigator:
          • Marcin Grabowski, M.D.
        • Sub-Investigator:
          • Agnieszka Kołodzińska, M.D.
        • Sub-Investigator:
          • Edyta Jakubik, M.D.
        • Sub-Investigator:
          • Diana Paskudzka, M.D.
      • Zabrze, Poland, 41-800
        • Recruiting
        • Silesian Center for Heart Diseases
        • Contact:
        • Principal Investigator:
          • Zbigniew Kalarus, Prof.
        • Sub-Investigator:
          • Adam Sokal, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is implanted with a Moderato® implantable pulse generator (IPG) and is being followed by the site per standard of care.
  • Subject has an average office systolic blood pressure > 130 mmHg and < 170 mmHg at the sub-study screening visit.

Exclusion Criteria:

  • Subject has permanent atrial fibrillation.
  • Subject had significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats) in the past month. Atrial fibrillation/flutter burden will be determined by interrogation of the Moderato pulse generator.
  • Subject experienced neurological events (stroke or TIA) within the past year. Subject have had a serious adverse event classified as related to CNT or the Backbeat Moderato device.
  • Female subject who is pregnant, breast-feeding, intends to become pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use contraception during the study.
  • Subject cannot or is unwilling to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure (SBP) between baseline (PHC ON) and PHC OFF at two consecutive time points: (a) after one day and (b) after a week of PHC OFF
Time Frame: one week
The first 24 hr of the first recording will be used to obtain the average for the baseline SBP value. As PHC is automatically turned OFF while the recording continues for another 24 hrs, the latter 24 hr will be used to obtain the average SBP of the first day with PHC OFF. A week later, the first 24 hr of the second recording will be used to obtain the average change in SBP to compare to the baseline (PHC ON).
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BackBeat Medical Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 27, 2021

Primary Completion (ANTICIPATED)

August 31, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (ACTUAL)

October 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNT Washout substudy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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