Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
9 maj 2026 uppdaterad av: Medtronic Cardiac Rhythm and Heart Failure
The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. In the control group, the pacing lower rate will be set to the nominal 60 bpm post a dual-chamber pacemaker implantation as frequently used in clinical practice, while in the allometric-pace group, the pacing rate will be programmed at 75 bpm based on the estimation for Chinese population with a height of 165-170 cm (also called personalized lower rate) or based on the symptom-relief per clinical assessment by the study physicians. Each patient will undergo baseline assessments and 3-month follow-up visits. At the enrollment and office visits, each patient will undergo arterial blood pressure measurement, cardiac functional assessment and cerebral blood flow measurement. At the end of the study, the study physician will adjust pacing lower rate based on patients' conditions and clinical assessments. After the completion of the study, all patients will have regular device follow-up visit, usually 6-month interval or annually.
Each patient will receive the following major assessments: device performance and pacing percentages, ventricular diastolic function by doppler and echocardiography of LVEF, LVEDV, LVESV, stroke volume, cardiac output, arterial blood pressure measurements, cerebral blood flow by MRI or Echo (which one will be determined later by the study PIs), and Mini-Mental State Examination (MMSE).
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
70
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Georgiana Zou
- Telefonnummer: +86 18918711140
- E-post: georgiana.zou@medtronic.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- ≥65 years of age
- Planned implantation of a dual chamber pacemaker with physiological pacing
- Resting sinus heart rate ≤60 bpm, or average 24 hour Holter heart rate ≤60 bpm
- Documented history of hypertension or office systolic blood pressure ≥130 mmHg
Exclusion Criteria:
- Diagnosis of secondary hypertension
- Diagnosis of or possible concomitant heart failure, with ejection fraction ≤50%
- Paroxysmal, persistent, or permanent atrial fibrillation
- Status post CABG or PCI
- Structural heart disease
- Risk of ventricular tachyarrhythmia
- Severe hepatic or renal dysfunction
- Active acute infection
- Inability to sign informed consent
- Pregnancy or planned pregnancy during the study period
- Enrollment in other clinical studies that may affect the objectives of this study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Personalized Lower Rate Pacing Group (75 bpm)
Participants in this group will receive dual-chamber pacemaker implantation per standard clinical practice.
After implantation, the device lower rate will be programmed to a personalized pacing rate of 75 beats per minute according to the study protocol.
Ventricular diastolic function, cerebral blood flow, cognitive function, and blood pressure will be assessed during follow-up.
|
The intervention consists of programming the pacemaker lower rate to a personalized setting of 75 beats per minute (personalized lower rate, PLR), based on clinical assessment.
The control condition uses the standard pacemaker lower rate programmed at 50-60 beats per minute.
No additional procedures beyond routine clinical practice are introduced.
|
|
Aktiv komparator: Conventional Lower Rate Pacing Group (60 bpm)
Participants in this group will receive dual-chamber pacemaker implantation per standard clinical practice.
After implantation, the device lower rate will be programmed to the conventional lower pacing rate of 60 beats per minute.
Outcome assessments during follow-up will be identical to those in the personalized pacing group.
|
The control intervention consists of programming the pacemaker lower rate to the standard clinical setting of 50-60 beats per minute, according to routine clinical practice.
No additional procedures or deviations from standard care are introduced.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Ventricular Diastolic Function and Cerebral Blood Flow
Tidsram: Baseline to 6 months post-implantation
|
In hypertensive patients with sinus node dysfunction treated with dual chamber pacemaker implantation, compared with the control group (pacemaker lower rate 50-60 bpm), to verify whether ventricular diastolic function and cerebral blood flow can be improved by personalized lower rate pacing (PLR) (75 bpm).
|
Baseline to 6 months post-implantation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cardiac Structure and Function Assessment
Tidsram: Baseline to 6 months post-implantation
|
To evaluate cardiovascular function using echocardiography and assess ventricular function, particularly diastolic function, using Doppler echocardiography.
|
Baseline to 6 months post-implantation
|
|
Cerebral Perfusion and Cognitive Function Assessment
Tidsram: Baseline to 6 months post-implantation
|
To evaluate cerebral cortical blood distribution and white matter changes using magnetic resonance imaging (MRI), and to assess cognitive function using the Mini Mental State Examination (MMSE).
|
Baseline to 6 months post-implantation
|
|
Arterial Blood Pressure Assessment
Tidsram: Baseline to 6 months post-implantation
|
To evaluate changes in arterial blood pressure using office blood pressure measurement and 24 hour ambulatory blood pressure monitoring.
|
Baseline to 6 months post-implantation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.
- Meyer M, LeWinter MM. Heart Rate and Heart Failure With Preserved Ejection Fraction: Time to Slow beta-Blocker Use? Circ Heart Fail. 2019 Aug;12(8):e006213. doi: 10.1161/CIRCHEARTFAILURE.119.006213. Epub 2019 Aug 1. No abstract available.
- Infeld M, Avram R, Wahlberg K, Silverman DN, Habel N, Lustgarten DL, Pletcher MJ, Olgin JE, Marcus GM, Meyer M. An approach towards individualized lower rate settings for pacemakers. Heart Rhythm O2. 2020 Dec;1(5):390-393. doi: 10.1016/j.hroo.2020.09.004. Epub 2020 Oct 6. No abstract available.
- Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.
- Changes in 24-hour ambulatory systolic blood pressure following pacemaker implantation in patients with sinus node dysfunction. Presented at the APHRS 2025 Scientific Sessions; 2025; Poster presentation.
- Infeld M, et al. Allometric-Based Pacing Rate Improves Quality of Life in Bradycardia Patients. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation.
- Infeld M, et al. A novel method to classify left bundle branch block with far-field intracardiac electrograms. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 maj 2026
Primärt slutförande (Beräknad)
31 januari 2028
Avslutad studie (Beräknad)
31 maj 2028
Studieregistreringsdatum
Först inskickad
9 maj 2026
Först inskickad som uppfyllde QC-kriterierna
9 maj 2026
Första postat (Faktisk)
15 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Allometric-Cerebral Study
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .