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

NCT ID: NCT03245996

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-09-30

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).

Conditions

Aortic Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Subjects

Subjects with a cardiac pacemaker

Group Type: EXPERIMENTAL

AAI 40 bpm

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

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

Atenolol Pill

Intervention Type: DRUG

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

Nebivolol Pill

Intervention Type: DRUG

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

Ivabradine Pill

Intervention Type: DRUG

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

Interventions

AAI 40 bpm

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Atenolol Pill

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

Intervention Type: DRUG

Nebivolol Pill

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

Intervention Type: DRUG

Ivabradine Pill

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

Intervention Type: DRUG

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;
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tartu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tuuli Teeäär

PhD Student, cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 32395337 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29581554 (View on PubMed)

Other Identifiers

14058

Identifier Type: -

Identifier Source: org_study_id