CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Pacemaker and defibrillatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07078487
NCT07078487N/ACompleted

Implications of Paced Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With Hypertension: a Randomised Crossover Study

University of Tartu·interventional·Posted Jul 22, 2025·Updated Jul 22, 2025

In Brief

A clinical study evaluating Pacemaker and defibrillator for Sick Sinus Syndrome and Hypertension. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEstonia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 22, 2025
Enrollment StartSep 21, 2020
Primary CompletionSep 10, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11 months ago

Interventions

Pacemaker and defibrillatordevice

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