Status:
COMPLETED
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
Lead Sponsor:
Tartu University Hospital
Conditions:
Aortic Blood Pressure
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 patie...
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 t...
Eligibility Criteria
Inclusion
- age 18-75 years;
- dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03245996
Start Date
June 1 2015
End Date
September 1 2016
Last Update
July 10 2018
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