The impact of heart rate on the effects of antihypertensive therapy on central and peripheral blood pressure

The Impact of Heart Rate on Central Hemodynamics of Antihypertensive Therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006090-25-EE

Enrollment

100

Registered

2011-12-29

Start date

2012-03-06

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with dual chamber (atrium and ventricle) cardiac pacemaker placed due to sick sinus syndrome (at least 1 month after implantation) MedDRA version: 17.1 Level: HLT Classification code 10053103 Term: Heart rate and pulse investigations System Organ Class: 100000004848

Interventions

Trade Name: Procoralan Product Name: ivabradine Pharmaceutical Form: Tablet INN or Proposed INN: IVABRADINE CAS Number: 155974-00-8 Concentration unit: mg milligram(s) Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-75 years Dual chamber (atrium and ventricle) cardiac pacemaker placed due to sick sinus syndrome (at least 1 month after implantation) Good atrioventricular conductance (PQ interval =65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: Patients with contraindication or intolerance to beta-blockers, ivabradine, or their adjuvants Use of antiarrythmic drugs (sotalol, amiodarone, propafenone) History of several episodes of atrial fibrillation Use of antibiotics Acute or chronic inflammatory diseases Resting blood pressure < 110/70 mmHg Atrioventricular conductance disorders (patient needs permanent pacing) Long QT interval on resting ECG Severe liver or kidney disorder Pregnant or breast-feeding women Women of child-bearing potential not using contraception Previous myocardial infarction or stroke Current stable angina pectoris Total cardiovascular risk higher than moderate-high (in first phase) No insurance provided by Estonian Health Insurance Fund

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of heart rate on the effects of antihypertensive therapy on central aortic blood pressure;Secondary Objective: To evaluate the impact of heart rate on the effects of antihypertensive therapy on pulse wave velocity, cardiac output, and peripheral vascular resistance;Primary end point(s): Change in central aortic blood pressure;Timepoint(s) of evaluation of this end point: First phase: at the day of first administration of the IMP and after 2 weeks of IMP therapy Second phase: after 24h of changing the pacemaker`s base rate	—

Measure

Time frame

Main Objective: To evaluate the impact of heart rate on the effects of antihypertensive therapy on central aortic blood pressure;Secondary Objective: To evaluate the impact of heart rate on the effects of antihypertensive therapy on pulse wave velocity, cardiac output, and peripheral vascular resistance;Primary end point(s): Change in central aortic blood pressure;Timepoint(s) of evaluation of this end point: First phase: at the day of first administration of the IMP and after 2 weeks of IMP therapy Second phase: after 24h of changing the pacemaker`s base rate

—

Secondary

Measure	Time frame
Secondary end point(s): Change in pulse wave velocity, cardiac output, and peripheral vascular resistance ;Timepoint(s) of evaluation of this end point: First phase: at the day of first administration of the IMP and after 2 weeks of IMP therapy Second phase: after 24h of changing the pacemaker`s base rate	—

Countries

Estonia

Contacts

Public ContactClinical Trials Information

University of Tartu, Clinic of Cardiology

priit.kampus@kliinikum.ee3727318457

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026