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NCT05086523
Cardiac Neuromodulation Therapy (CNT) "Washout" Sub-Study
Phase 1, PHASE2 trial testing Programmable Hypertension Control (BackBeat Moderato) in Hypertension,Essential in 28 participants. Status unknown.
31 August 2023
Quick facts
| Lead sponsor | BackBeat Medical Inc |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 28 |
| Start date | 27 September 2021 |
| Primary completion | 31 August 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 6 locations across Poland, Hungary, Czechia |
Drugs / interventions tested
- Programmable Hypertension Control (BackBeat Moderato)
- Pacing (BackBeat Moderato)
Conditions studied
- Hypertension,Essential — all drugs for Hypertension,Essential →
- Systolic Hypertension — all drugs for Systolic Hypertension →
Sponsor
BackBeat Medical Inc — full company profile →
Who can join
18 and older, any sex, with Hypertension,Essential or Systolic Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05086523
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other BackBeat Medical Inc trials
Trials by the same sponsor.
- NCT05719454 — Novel Setup Algorithm for Cardiac Neuromodulation Therapy · NA · recruiting
- NCT05345925 — PV Loops With CNT in Multiple Pacing Sites · NA · unknown
- NCT04573699 — Cardiac Neuromodulation for Heart Failure · unknown
- NCT04463121 — Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06) · NA · unknown
- NCT03757377 — Moderato System in Patients With Hypertension · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05086523 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BackBeat Medical Inc
- Last refreshed: 3 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05086523.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing