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Trial record 78 of 117 for:    Atenolol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245996
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Tuuli Teeäär, Tartu University Hospital

Tracking Information
First Submitted Date  ICMJE August 8, 2017
First Posted Date  ICMJE August 10, 2017
Last Update Posted Date July 10, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • First part of the study: central systolic blood pressure [ Time Frame: 3 minutes after heart rate change ]
  • Second part of the study: systolic blood pressure amplification [ Time Frame: 3 hours after drug administration and 3 minutes after heart rate change ]
    difference between peripheral and central systolic blood pressure
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
central systolic blood pressure [ Time Frame: 3 minutes after heart rate change ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
Official Title  ICMJE The Impact of Heart Rate on Central Hemodynamics in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Basic Science
Condition  ICMJE Aortic Blood Pressure
Intervention  ICMJE
  • Device: AAI 40 bpm
    Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study
  • 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
  • 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
  • Drug: Atenolol Pill
    50 or 100 mg of atenolol is administered to subjects in the second part of the study
  • Drug: Nebivolol Pill
    5 mg of nebivolol is administered to subjects in the second part of the study
  • Drug: Ivabradine Pill
    5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study
Study Arms  ICMJE Experimental: Subjects
Subjects with a cardiac pacemaker
Interventions:
  • Device: AAI 40 bpm
  • Device: AAI 60 bpm
  • Device: AAI 90 bpm
  • Drug: Atenolol Pill
  • Drug: Nebivolol Pill
  • Drug: Ivabradine Pill
Publications * Teeäär 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2017)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03245996
Other Study ID Numbers  ICMJE 14058
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all data shared after completion of study as supplement to journal article
Responsible Party Tuuli Teeäär, Tartu University Hospital
Study Sponsor  ICMJE Tartu University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tartu University Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP