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NCT03757377
Moderato System in Patients With Hypertension
NA trial testing BackBeat Moderato System in Hypertension, Resistant to Conventional Therapy in 203 participants. Status unknown.
1 February 2021
Quick facts
| Lead sponsor | BackBeat Medical Inc |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 203 |
| Start date | 30 August 2017 |
| Primary completion | 1 February 2021 |
| Estimated completion | 30 March 2023 |
| Sites | 4 locations across Belgium, Lithuania, Poland |
Drugs / interventions tested
- BackBeat Moderato System
- BackBeat Moderato Sytsem
Conditions studied
- Hypertension, Resistant to Conventional Therapy — all drugs for Hypertension, Resistant to Conventional Therapy →
- Atrioventricular Block — all drugs for Atrioventricular Block →
Sponsor
BackBeat Medical Inc — full company profile →
Who can join
18 and older, any sex, with Hypertension, Resistant to Conventional Therapy or Atrioventricular Block. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a dual chamber pacemaker in order to reduce their blood pressure. In this amended CS-03 protocol Version 3.0, the study will evaluate the safety and efficacy in a randomized, double-blind study following active treatment vs. a control patient population for a period of 3 month for efficacy and 12 months for safety (In comparison to 6 months for patients under protocol CS-03 Ver 1.1, NCT02837445). The device will be considered to have a clinical effectiveness with regard to its anti-hypertension function if there is a statistically significant and clinically meaningful reduction in mean 24-hour ambulatory systolic blood pressure in the treatment group compared to the control group. The primary efficacy endpoint will be evaluated 3 months after randomization. The Primary safety analysis will compare the treatment and the control after 12 months of treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Implant-Mediated Therapy of Arterial Hypertension.
Gierthmuehlen M, Plachta DTT, Zentner J. · · 2020 · cited 10× · PMID 32030509 · DOI 10.1007/s11906-020-1019-7 -
Resistant Blood Pressure: New Frontiers in Interventional Hypertension Therapy.
Taylor JD, Uche C, Rowe V, Hattab A, et al · · 2025 · PMID 41071478 · DOI 10.1007/s40119-025-00434-4
Verify or expand the search:
- PubMed search for NCT03757377
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertension, Resistant to Conventional Therapy
Currently open trials in the same condition.
- NCT05017935 — RADIANCE Continued Access Protocol · NA · active not recruiting
- NCT02057783 — Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension · NA · recruiting
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
- NCT05086523 — Cardiac Neuromodulation Therapy (CNT) "Washout" Sub-Study · Phase 1, PHASE2 · unknown
- NCT04573699 — Cardiac Neuromodulation for Heart Failure · unknown
- NCT04463121 — Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06) · 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 NCT03757377 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 14 December 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/NCT03757377.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing