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

NCT05086523 | Unknown Phase 1

• 1 other identifier: CNT Washout substudy
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Hypertension,Essential; Systolic Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  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

Interventions

Programmable Hypertension Control (BackBeat Moderato) DEVICE

Programmable Hypertension Control can be turned OFF without affecting regular pacing

Pacing (BackBeat Moderato) DEVICE

Programmable Hypertension Control can be turned OFF without affecting regular pacing

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BackBeat Medical Inc: lead

Study Sites (6)

Na Homolce Hospital

Prague, 15030, Czechia

COMPLETED

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

COMPLETED

Szpital Kliniczny Przemiemienia Panskiego

Poznan, 61-848, Poland

NOT YET RECRUITING

Pomeranian Medical University Hospital no. 2

Szczecin, 70-111, Poland

NOT YET RECRUITING

Samodzielnym Publicznym Centralnym Szpitalem Klinicznym

Warsaw, 02-097, Poland

NOT YET RECRUITING

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

RECRUITING

Related Publications (3)

• Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.

  PMID: 26699604 BACKGROUND

• Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.

  PMID: 32034481 BACKGROUND

• Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.

  PMID: 28859944 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension; Isolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuval Mika, Ph.D.

CONTACT

+18569123155; ymika@orchestrabiomed.com

Norbert Rosenthal, B.Sc.

CONTACT

+491792482543; nrosenthal@orchestrabiomed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: each patient serves as his/her own control, in the PHC ON (baseline) to OFF transition (early time point), then a week later again, the OFF value (late time point) will be compared to baseline.

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 21, 2021
• Study Start: September 27, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

PL (4); CZ (1); HU (1)