Hypertension, Resistant to Conventional TherapyNCT03757377
Moderato System in Patients With Hypertension
A study testing BackBeat Moderato System and BackBeat Moderato Sytsem in people with Hypertension, Resistant to Conventional Therapy and Atrioventricular Block, run by BackBeat Medical Inc at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy, Atrioventricular Block
- What is being tested?
- BackBeat Moderato System and BackBeat Moderato Sytsem
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Aug 2017to 13 May 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirement of dual chamber pacemaker or upgrade from a single chamber to a dual chamber pacemaker.
- Stable (at least 6 weeks) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained without changes. Stable is defined as being in the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks.
- Average 24-hour ambulatory systolic blood pressure ≥ 130 mmHg (with directly observed medical therapy, DOT) and office blood pressure ≥140 mmHg.
- Subject is able to comply with study visits for at least 13 months (e.g., is capable and willing to travel to/from the center for all scheduled study visits).
Who cannot join
- Known secondary cause of HTN.
- Average ambulatory or office systolic BP > 195 mmHg.
- Permanent atrial fibrillation.
- History of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats).
- Cardiac ejection fraction <50%.
- Symptoms of heart failure, NYHA Class II or greater.
Show all 17Show fewer
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy or inter-ventricular septal thickness ≥ 15 mm.
- Subject is on dialysis.
- Subject has an estimated Glomerular Filtration Rate < 30 ml/min/1.73 m²
- Prior neurological events (stroke or TIA) within the past year or events at a prior time that has resulted in residual neurologic deficit.
- Carotid artery disease.
- Known autonomic dysfunction.
- History of clinically significant untreated ventricular tachyarrhythmia or has experienced cardiac arrest.
- Previous active device-based treatment for HTN.
- Existing implant, other than a pacemaker that needs replacing.
- Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study.
- Subject is unwilling or cannot provide Informed Consent
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Poland2 sites
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, 02-097
Silesian Center for Heart Diseases
Zabrze, 41-800
Lithuania1 site
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
About this study
Official title: Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial
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.
Read the detailed description
Protocol CS-03 Ver 1.1 (NCT02837445) was amended at the advice of the Scientific Advisory to protocol CS-03 Version 3.0 with more stringent hypertension inclusion criteria and different observation intervals for efficacy and safety.
In CS-03 Version 3.0 the time of the primary efficacy endpoint was reduced from 6 months to 3 months post randomization which was deemed a suitable interval for the chronic effect, whereas for the safety endpoint, the period was lengthened to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 months to 12 months). Protocols were thus split in order to allow better clarification to the difference in the time to the primary endpoints for efficacy and safety between the two CIP versions and simplify data analysis.
Protocol Ver 3.0 prescribes data analysis of all patients randomized under version 1.1 to be performed once they complete the 6 months follow-up as set in protocol version 1.1 (NCT0283744). It is expected that ~40 patients will be randomized according to protocol version 1.1 prior to the enrollment of patients according to protocol version 3.0. The results will be considered as interim analysis.
The recruitment for the protocol version 1.1 is now completed. Total of 47 patients were randomized according to protocol version 1.1 and all patients completed the follow-up period for the primary endpoint.
Patients are currently being followed up for the study "extension period".
- Being tested
- BackBeat Moderato System, BackBeat Moderato Sytsem
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BackBeat Moderato SystemDevice
Eligible patients randomized after optimization phase to PHC ON for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
BackBeat Moderato SytsemDevice
Eligible patients randomized after optimization phase to PHC OFF for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| BackBeat Moderato System (PHC ON) | Active comparator | Eligible patients randomized after optimization phase to PHC ON (PHC algorithm active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator. Receives: Device: BackBeat Moderato System |
| BackBeat Moderato System (PHC OFF) | Placebo comparator | Eligible patients randomized after optimization phase to pacemaker only (PHC OFF or PHC algorithm not active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator. Receives: Device: BackBeat Moderato Sytsem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of composite of major cardiac events
including heart failure, clinically significant arrhythmias eg, persistent or increased atrial fibrillation, serious ventricular arrhythmias, myocardial infarction, stroke, heart failure, renal failure and/or related safety events that result in death
Measured: 12 months post Randomization
Change in average 24 hour systolic ambulatory blood pressure
Measured: Week 3 pre Randomization and 3 months post Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start30 Aug 2017
- Primary completion13 May 2021
- Study completion13 May 2021
Why it stopped: Interim analysis showed that endpoints could be achieved with a smaller cohort
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, Prof. MD, Principal investigator, Asklepios Klinik St. Georg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757377
- Sponsor's protocol ID
- CS-03 Ver 3.0
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2018
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No