Pacemaker upgrade aims to tame high blood pressure
NCT ID NCT05719454
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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The places running it
7 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jagiellonian University Hospital
NOT_YET_RECRUITINGKrakow, 30-688, Poland
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Nemocnice Na Homolce (Na Homolce Hospital)
NOT_YET_RECRUITINGPrague, 15030, Czechia
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Publiczny Centralny Szpital
NOT_YET_RECRUITINGWarsaw, 02-097, Poland
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Samodzielny Pub. Szpital Kliniczny nr 2 PUM
NOT_YET_RECRUITINGSzczecin, 72 70-111, Poland
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Semmelweis University Heart and Vascular Center
RECRUITINGBudapest, 1122, Hungary
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Silesian Center for Heart Diseases
NOT_YET_RECRUITINGZabrze, 41-800, Poland
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Uniwersytecki Szpital Kliniczny w Poznaniu
NOT_YET_RECRUITINGPoznan, 61-848, Poland
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