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Completed

NCT Number: NCT03245996

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

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AAI 40 bpm

Device

Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study

AAI 60 bpm

Device

Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study

AAI 90 bpm

Device

Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study

Atenolol Pill

Drug

50 or 100 mg of atenolol is administered to subjects in the second part of the study

Nebivolol Pill

Drug

5 mg of nebivolol is administered to subjects in the second part of the study

Ivabradine Pill

Drug

5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study

Primary outcomes

  1. First part of the study: central systolic blood pressure

    Time frame: 3 minutes after heart rate change

  2. Second part of the study: systolic blood pressure amplification

    Time frame: 3 hours after drug administration and 3 minutes after heart rate change

    difference between peripheral and central systolic blood pressure

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2017
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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