Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Pacemaker upgrade aims to tame high blood pressure

NCT ID NCT05719454

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new way to program pacemakers to help lower blood pressure in people who have both high blood pressure and a slow heart rate. About 30 adults who already have or need a special pacemaker will try two different setup sessions. Researchers will check if the new settings safely reduce blood pressure over 12 months.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

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 ≥ 18 years of age * Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker. * Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive drugs, which is planned to be maintained without changes for a period of at least 2 months post implant. * Subject has an office systolic blood pressure (oSBP) ≥140 and \<180 mmHg * At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \<170 mmHg and an office blood pressure (oSBP) ≥140 and \<180 mmHg. * Subject is willing and able to comply with study visits and procedures * Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study. Exclusion Criteria: * 1\. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma) * Subject has permanent atrial fibrillation * Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., \>10% atrial fibrillation/flutter beats if available. * Subject has an ejection fraction \<50% * Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4 * Subject has symptoms of heart failure, NYHA Class II or greater * Subject has mitral regurgitation ≥2+, aortic stenosis with valve area \<1.0 cm2 , or is expected to need a valve repair or replacement. * Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score \>2+) * Subject experienced myocardial infarction (MI) within 3 months prior to enrolment * Subject had a cardiovascular interventional procedure or cardiovascular surgery within 6 months prior to enrolment * Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm * Subject is on dialysis * Subject has estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m² * Subject has significant (\>50% occlusion of left or right carotid artery) carotid artery stenosis * Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest * Subject has an active device-based treatment for hypertension * Subject has an existing active cardiac device or neurostimulator (e.g., ICD, spinal cord stimulator) * Subject has Type I Diabetes * Subject is a member of a vulnerable population (e.g., prisoners, pregnant or lactating women, mentally disabled) * Subject has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study * Subject cannot or is unwilling to provide informed consent

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bradycardia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jagiellonian University Hospital

    NOT_YET_RECRUITING

    Krakow, 30-688, Poland

  • Nemocnice Na Homolce (Na Homolce Hospital)

    NOT_YET_RECRUITING

    Prague, 15030, Czechia

  • Publiczny Centralny Szpital

    NOT_YET_RECRUITING

    Warsaw, 02-097, Poland

  • Samodzielny Pub. Szpital Kliniczny nr 2 PUM

    NOT_YET_RECRUITING

    Szczecin, 72 70-111, Poland

  • Semmelweis University Heart and Vascular Center

    RECRUITING

    Budapest, 1122, Hungary

  • Silesian Center for Heart Diseases

    NOT_YET_RECRUITING

    Zabrze, 41-800, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    NOT_YET_RECRUITING

    Poznan, 61-848, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.