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Effect of Paced HR on Central BP

NCT07078487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-22

No results posted yet for this study

Summary

Central (aortic) blood pressure predicts heart, brain and kidney complications more reliably than the usual peripherally measured blood pressure. Heart rate has a strong and sometimes counter-intuitive influence on central blood pressure. Pacemakers implanted due to sick sinus syndrome (SSS) are typically programmed anywhere between 55-75 beats per minute (bpm), yet it is unclear which rate gives hypertensive pacemaker recipients the most favourable central hemodynamics.

This single-center, randomized, single-blind, two-period cross-over trial will enrol 20 adults (18-80 years) who already carry a dual-chamber pacemaker for SSS, are in sinus rhythm, and have medication-controlled arterial hypertension. Each participant will complete two eight-week pacing periods in random order:

* "Slow" period - pacemaker lower-rate set to 55 bpm.
* "Fast" period - pacemaker lower-rate set to 75 bpm.

A two-week wash-out at the device's usual settings separates the periods. At baseline and after each intervention the team will perform non-invasive pulse-wave analysis (SphygmoCor XCEL) to obtain central systolic blood pressure (primary endpoint) and arterial stiffness indices such as augmentation index and pulse-wave velocity (secondary endpoints). Pacemaker function, symptoms and safety events are reviewed at every visit; settings can be adjusted by ±5 bpm if troublesome symptoms occur.

The study will provide the first long-term evidence on how fixed pacing rates modulate central blood pressure in real-world SSS patients with hypertension, potentially guiding clinicians toward the optimal programming strategy.

Conditions

Interventions

DEVICE

Pacemaker and defibrillator

Setting the pacemaker base rate at a pre-defined base rate

Sponsors & Collaborators

  • University of Tartu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2024-09-10
Completion
2024-09-10

Countries

  • Estonia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078487 on ClinicalTrials.gov