NCT03245996

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Tartu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied. * To investigate the role of non-pharmacological heart rate change on central hemodynamics in the first part of the study, the investigators acutely change pacing rate from atrial paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters noninvasively after a short stabilisation period after each pacemaker rate change. * Subsequently, to investigate the acute effects of beta-blockers or ivabradine on central hemodynamics in the second part of the study, the investigators obtain central hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol or ivabradine at the same pacing rate levels used in the first part of the study (AAI-mode 60, 40 and 90 bpm).

Conditions

• Aortic Blood Pressure

Interventions

Type	Name	Description
DEVICE	AAI 40 bpm	Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study
DEVICE	AAI 60 bpm	Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study
DEVICE	AAI 90 bpm	Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study
DRUG	Atenolol Pill	50 or 100 mg of atenolol is administered to subjects in the second part of the study
DRUG	Nebivolol Pill	5 mg of nebivolol is administered to subjects in the second part of the study
DRUG	Ivabradine Pill	5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2017-08-10
• Last updated: 2018-07-10