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

NCT03245996 | Completed Phase 4

• 1 other identifier: 14058
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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

Conditions

Aortic Blood Pressure

Keywords

sick sinus syndrome; heart rate; aortic blood pressure; artificial pacemaker; beta-blockers; ivabradine

Outcome Measures

Primary Outcomes (2)

• First part of the study: central systolic blood pressure

  3 minutes after heart rate change

• Second part of the study: systolic blood pressure amplification

  difference between peripheral and central systolic blood pressure

  3 hours after drug administration and 3 minutes after heart rate change

Study Arms (1)

Subjects

EXPERIMENTAL

Subjects with a cardiac pacemaker

Device: AAI 40 bpm; Device: AAI 60 bpm; Device: AAI 90 bpm; Drug: Atenolol Pill; Drug: Nebivolol Pill; Drug: Ivabradine Pill

Interventions

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

Subjects

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

Subjects

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

Subjects

Atenolol Pill DRUG

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

Subjects

Nebivolol Pill DRUG

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

Subjects

Ivabradine Pill DRUG

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

Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75 years;
• dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tartu University Hospital: lead

Related Publications (2)

• Teeaar T, Serg M, Paapstel K, Vahi M, Kals J, Cockcroft JR, Zilmer M, Eha J, Kampus P. Atenolol's Inferior Ability to Reduce Central vs Peripheral Blood Pressure Can Be Explained by the Combination of Its Heart Rate-Dependent and Heart Rate-Independent Effects. Int J Hypertens. 2020 Apr 26;2020:4259187. doi: 10.1155/2020/4259187. eCollection 2020.

  PMID: 32395337 DERIVED

• Teeaar T, Serg M, Paapstel K, Kals J, Kals M, Zilmer M, Eha J, Kampus P. Heart rate reduction decreases central blood pressure in sick sinus syndrome patients with a permanent cardiac pacemaker. J Hum Hypertens. 2018 May;32(5):377-384. doi: 10.1038/s41371-018-0051-4. Epub 2018 Mar 27.

  PMID: 29581554 DERIVED

MeSH Terms

Conditions

Sick Sinus Syndrome

Interventions

Atenolol; Nebivolol; Ivabradine

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Ethanolamines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, cardiologist

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 10, 2017
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share