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

• Conditions: Patients with dual chamber (atrium and ventricle) cardiac pacemaker placed due to sick sinus syndrome (at least 1 month after implantation); MedDRA version: 17.1Level: HLTClassification code 10053103Term: Heart rate and pulse investigationsSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-006090-25-EE
• Lead Sponsor: Tartu Ülikooli kardioloogiakliinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 250 msec)
Study subject has signed the informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified