Back to resultsThe Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
Primary Purpose
Aortic Blood Pressure
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
AAI 40 bpm
AAI 60 bpm
AAI 90 bpm
Atenolol Pill
Nebivolol Pill
Ivabradine Pill
Sponsored by
About this trial
This is an interventional basic science trial for Aortic Blood Pressure focused on measuring sick sinus syndrome, heart rate, aortic blood pressure, artificial pacemaker, beta-blockers, ivabradine
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects
Arm Description
Subjects with a cardiac pacemaker
Outcomes
Primary Outcome Measures
First part of the study: central systolic blood pressure
Second part of the study: systolic blood pressure amplification
difference between peripheral and central systolic blood pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03245996
Brief Title
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
Official Title
The Impact of Heart Rate on Central Hemodynamics in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tartu University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Blood Pressure
Keywords
sick sinus syndrome, heart rate, aortic blood pressure, artificial pacemaker, beta-blockers, ivabradine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects
Arm Type
Experimental
Arm Description
Subjects with a cardiac pacemaker
Intervention Type
Device
Intervention Name(s)
AAI 40 bpm
Intervention Description
Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study
Intervention Type
Device
Intervention Name(s)
AAI 60 bpm
Intervention Description
Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study
Intervention Type
Device
Intervention Name(s)
AAI 90 bpm
Intervention Description
Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study
Intervention Type
Drug
Intervention Name(s)
Atenolol Pill
Intervention Description
50 or 100 mg of atenolol is administered to subjects in the second part of the study
Intervention Type
Drug
Intervention Name(s)
Nebivolol Pill
Intervention Description
5 mg of nebivolol is administered to subjects in the second part of the study
Intervention Type
Drug
Intervention Name(s)
Ivabradine Pill
Intervention Description
5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study
Primary Outcome Measure Information:
Title
First part of the study: central systolic blood pressure
Time Frame
3 minutes after heart rate change
Title
Second part of the study: systolic blood pressure amplification
Description
difference between peripheral and central systolic blood pressure
Time Frame
3 hours after drug administration and 3 minutes after heart rate change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all data shared after completion of study as supplement to journal article
Citations:
PubMed Identifier
32395337
Citation
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.
Results Reference
derived
PubMed Identifier
29581554
Citation
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.
Results Reference
derived
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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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