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Trial record 5 of 63 for:    "sick sinus syndrome" OR "sinus node disease" OR "sinus node dysfunction"

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 : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Tuuli Teeäär, Tartu University Hospital

Brief Summary:
This study evaluates the acute effects of heart rate (HR) change on central hemodynamic parameters noninvasively.

Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome Device: AAI 40 bpm Device: AAI 60 bpm Device: AAI 90 bpm Not Applicable

Detailed Description:
Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied. To investigate the role of heart rate on central hemodynamics, we acutely change pacing rate from atrial paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters (brachial and aortic blood pressure, brachial and aortic pulse pressure, central augmentation index, carotid-femoral pulse wave velocity) noninvasively after a short stabilisation period after each pacemaker rate change.

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

Device: AAI 60 bpm
Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm

Device: AAI 90 bpm
Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm




Primary Outcome Measures :
  1. central systolic blood pressure [ Time Frame: 3 minutes after heart rate change ]


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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

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: August 10, 2017
Last Verified: August 2017
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

Additional relevant MeSH terms:
Syndrome
Sick Sinus Syndrome
Disease
Pathologic Processes
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block