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

Tartu University Hospital0 sites27 target enrollmentJune 2015

ConditionsAortic Blood Pressure

InterventionsAAI 40 bpm AAI 60 bpm AAI 90 bpm Atenolol Pill Nebivolol Pill Ivabradine Pill

DrugsAtenolol Pill Nebivolol Pill Ivabradine Pill

Overview

Phase: Phase 4
Intervention: AAI 40 bpm
Conditions: Aortic Blood Pressure
Sponsor: Tartu University Hospital
Enrollment: 27
Primary Endpoint: First part of the study: central systolic blood pressure
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

September 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tartu University Hospital

Responsible Party

Principal Investigator

Tuuli Teeäär

PhD Student, cardiologist

Tartu University Hospital

Eligibility 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;