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

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ClinicalTrials.gov Identifier: NCT03245996
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Tuuli Teeäär, Tartu University Hospital

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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 : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Tuuli Teeäär, PhD Student, cardiologist, Tartu University Hospital
ClinicalTrials.gov Identifier: NCT03245996     History of Changes
Other Study ID Numbers: 14058
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all data shared after completion of study as supplement to journal article

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tuuli Teeäär, Tartu University Hospital:
sick sinus syndrome
heart rate
aortic blood pressure
artificial pacemaker
beta-blockers
ivabradine

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes
Nebivolol
Atenolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists