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

Sponsor

Tartu University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03245996

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Blood Pressure	Device: AAI 40 bpm Device: AAI 60 bpm Device: AAI 90 bpm Drug: Atenolol Pill Drug: Nebivolol Pill Drug: Ivabradine Pill	Phase 4

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects Subjects with a cardiac pacemaker	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

Arm

Intervention/Treatment

Experimental: Subjects

Subjects with a cardiac pacemaker

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

Outcome Measures

Primary Outcome Measures

First part of the study: central systolic blood pressure [3 minutes after heart rate change]
Second part of the study: systolic blood pressure amplification [3 hours after drug administration and 3 minutes after heart rate change]
difference between peripheral and central systolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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