Could a pacemaker tame stubborn high blood pressure?

NCT ID NCT02837445

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

Summary

This trial tests a special pacemaker-like device, the Moderato System, designed to lower blood pressure in people who have resistant hypertension and already need a dual-chamber pacemaker. Participants are randomly assigned to have the device's blood-pressure-lowering feature turned on or off for six months, while continuing their usual blood pressure medications. The study measures safety and whether the device significantly reduces average systolic blood pressure over 24 hours.

What this could mean

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

Active substance
BackBeat Medical Moderato System (implantable pulse generator with PHC therapy)
What this could lead to
If effective, this device could offer a new way to control blood pressure in people who already need a pacemaker, potentially reducing the need for additional medications.
What could go wrong
This is a small, early-stage trial with only 70 participants, so results may not apply to everyone. The device is implanted and carries risks like infection, arrhythmia, or device malfunction.

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia Hypertension Resistant to Conventional Therapy hypertensive disorder resistant hypertension

As listed by the trial registrant

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

Contacts and locations

Locations

  • Krankenhaus der Elisabethinen

    Linz, 4020, Austria

  • Medical University Vienna

    Vienna, 1090, Austria

  • Medical University of Gdansk

    Gdansk, 80-952, Poland

  • Na Homolce Hospital

    Prague, 15030, Czechia

  • P. Stradins Clinical University Hospital

    Riga, 1002, Latvia

  • 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

  • UZ Brussel - Heart Rhythm Management Center

    Brussels, 1090, Belgium

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 08661, Lithuania

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