NCT07078487Completed
Effect of Paced HR on Central BP
Implications of Paced Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With Hypertension: a Randomised Crossover Study
Source: ClinicalTrials.gov · Last updated 22 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 11 Jul 2025
- Start date
- 21 Sept 2020
- Primary completion date
- 10 Sept 2024
- Lead sponsor
- University of Tartu
- Diseases
- High blood pressure
- NCT number
- NCT07078487
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 21 Sept 2020 to the primary completion date, 10 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Significant AV block, paced QRS ≥ 130 ms, \>3 antihypertensives, digoxin or class Ic/III/IV antiarrhythmics, frequent atrial tachyarrhythmia (\>3% AMS episodes), coronary intervention on \>1 vessel, LVEF ≤ 40%, CRT or ICD, significant valvular disease, congenital heart disease, BMI ≥ 35 kg/m², diabetes with complications or on insulin, advanced renal, hepatic or pulmonary disease, systemic inflammatory disease, malignancy under recent active therapy, pregnancy or lactation, substance misuse, or inability to complete follow-up.
Who the study is looking for
- Age 18-80 years.
- Dual-chamber pacemaker implanted ≥3 months for SSS.
- Sinus rhythm; atrial pacing \>80%, ventricular pacing \<3% since last device check.
- Medication-treated primary hypertension with clinic BP \< 140/90 mmHg and home BP \< 135/85 mmHg.
- Able to provide informed consent and comply with procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North Estonia Medical Centre Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.