Effect of Paced HR on Central BP

NCT07078487 | Completed

• 1 other identifier: 299/T-22
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Sick Sinus Syndrome; Hypertension

Keywords

heart rate; hypertension; sick sinus syndrome; arterial pressure; pulse wave analysis

Outcome Measures

Primary Outcomes (1)

• Central systolic blood pressure

  Central (aortic) systolic blood pressure measured non-invasively using pulse wave analysis (SphygmoCor XCEL) with brachial cuff acquisition and generalized transfer function to derive central waveforms. Measurements taken in standardized seated position in clinical setting.

  After each 8-week intervention period (at week 8 and week 18 of study participation)

Secondary Outcomes (5)

• Central diastolic blood pressure

  After each 8-week intervention period (at week 8 and week 18 of study participation)

• Augmentation index

  After each 8-week intervention period (at week 8 and week 18 of study participation)

• Pulse wave velocity

  After each 8-week intervention period (at week 8 and week 18 of study participation)

• Brachial blood pressure

  After each 8-week intervention period (at week 8 and week 18 of study participation)

• Pulse pressure amplification

  After each 8-week intervention period (at week 8 and week 18 of study participation)

Study Arms (2)

"Slow" arm

EXPERIMENTAL

Pacemaker base rate set at 55 bpm

Device: Pacemaker and defibrillator

"Fast" arm

EXPERIMENTAL

Pacemaker base rate set at 75 bpm

Device: Pacemaker and defibrillator

Interventions

Pacemaker and defibrillator DEVICE

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

"Fast" arm; "Slow" arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

North Estonia Medical Centre

Tallinn, Harju, 13419, Estonia

Location

Related Publications (4)

• Hashimoto J. Pulse pressure amplification as a hemodynamic predictor of cardiovascular disease. Hypertens Res. 2024 Nov;47(11):3270-3272. doi: 10.1038/s41440-024-01880-8. Epub 2024 Sep 11. No abstract available.

  PMID: 39261706 BACKGROUND

• Fong DT, Yam KY, Chu VW, Cheung RT, Chan KM. Upper limb muscle fatigue during prolonged Boccia games with underarm throwing technique. Sports Biomech. 2012 Nov;11(4):441-51. doi: 10.1080/14763141.2012.699977.

  PMID: 23259234 BACKGROUND

• Ikeda S, Shinohara K, Enzan N, Matsushima S, Tohyama T, Funakoshi K, Kishimoto J, Itoh H, Komuro I, Tsutsui H. A higher resting heart rate is associated with cardiovascular event risk in patients with type 2 diabetes mellitus without known cardiovascular disease. Hypertens Res. 2023 May;46(5):1090-1099. doi: 10.1038/s41440-023-01178-1. Epub 2023 Jan 27.

  PMID: 36707715 BACKGROUND

• Fox K, Borer JS, Camm AJ, Danchin N, Ferrari R, Lopez Sendon JL, Steg PG, Tardif JC, Tavazzi L, Tendera M; Heart Rate Working Group. Resting heart rate in cardiovascular disease. J Am Coll Cardiol. 2007 Aug 28;50(9):823-30. doi: 10.1016/j.jacc.2007.04.079. Epub 2007 Aug 13.

  PMID: 17719466 BACKGROUND

MeSH Terms

Conditions

Sick Sinus Syndrome; Hypertension

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Priit Kampus

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: September 21, 2020
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

ES (1)