The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is divided into two parts:

• The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker

• The second part evaluates the acute effects of atenolol, nebivolol and ivabradine on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tartu University Hospital
• Treatments: Atenolol; Nebivolol

Criteria

Inclusion Criteria:

• age 18-75 years;

• dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm

Exclusion Criteria:

• average seated office brachial systolic BP ≥160 mmHg and/or diastolic BP ≥ 100 mmHg; atrial pacing <40%;

• ventricular pacing >25%;

• unpaced QRS >120 ms and/or QTc >500 ms on 12-lead ECG;

• atrioventricular blockage at AAI-mode 90 bpm; resting HR >60 bpm at AAI-mode 40 bpm; irregular heart rate;

• automatic mode switching >10%;

• implantable cardioverter defibrillator or cardiac resynchronisation therapy pacemaker; treatment with digoxin, class Ic or III antiarrhythmic drugs;

• history of acute coronary syndrome;

• stable angina pectoris;

• heart failure with reduced left ventricular ejection fraction;

• history of cerebrovascular event;

• diabetes mellitus;

• chronic kidney disease with eGFR <30 ml/min/m2;

• peripheral artery disease;

• clinically relevant heart valve disease;

• active cancer;

• acute or chronic inflammatory disease;

• severe chronic respiratory or liver disease;

• pregnancy or breastfeeding

• contraindication or intolerance to atenolol, nebivolol, ivabradine or adjuvants