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Pacemaker tweak may quietly lower blood pressure without extra pills

NCT ID NCT05086523

Disease control Sponsor: BackBeat Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a special pacemaker called the BackBeat Moderato that can adjust its pacing to help control high blood pressure. Researchers will turn the device on and off for short periods in 28 people who already have the pacemaker implanted, measuring how their blood pressure changes. The goal is to see if the device can safely lower systolic blood pressure when active.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BackBeat Moderato device (programmable hypertension control via pacemaker)
What this could lead to
If it works, this could offer a new way to manage high blood pressure using a pacemaker, potentially reducing the need for daily pills.
What could go wrong
This is a small, early-phase study with only 28 participants, so results may not apply to everyone. The device requires implantation, which carries surgical risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

28 people

The number who actually took part.

Started

Oct 2021

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

essential hypertension essential hypertension, genetic hypertensive disorder Isolated Systolic Hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension,essential Systolic hypertension

Contacts and locations

Locations

  • Na Homolce Hospital

    Prague, 15030, Czechia

  • Pomeranian Medical University Hospital no. 2

    Szczecin, 70-111, Poland

  • Samodzielnym Publicznym Centralnym Szpitalem Klinicznym

    Warsaw, 02-097, Poland

  • Semmelweis University Heart and Vascular Center

    Budapest, 1122, Hungary

  • Silesian Center for Heart Diseases

    Zabrze, 41-800, Poland

  • Szpital Kliniczny Przemiemienia Panskiego

    Poznan, 61-848, Poland

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