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Long-term Atrial Pacing and Central Blood Pressure

Primary Purpose

Blood Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
base rate programming of a permanent cardiac pacemaker
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure focused on measuring central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-80 years
  • sick sinus syndrome
  • permanent cardiac pacemaker with right atrial and right ventricular leads
  • at least 3 months from implantation
  • sinus rhythm
  • percentage of atrial pacing at or above 80% since last interrogation
  • percentage of ventricular pacing at or below 3% since last interrogation
  • primary arterial hypertension
  • antihypertensive drug treatment
  • mean office brachial blood pressure below 140/90 mmHg
  • mean home brachial blood pressure below 135/85 mmHg
  • ability to understand and follow study protocol
  • signed informed consent form

Exclusion Criteria:

  • inclusion criteria not fulfilled
  • violation of study protocol by subject, investigator or third part
  • high quality central hemodynamic measurements cannot be perfomed
  • inter-arm difference in brachial systolic blood pressure 15 mmHg or above
  • intrinsic QRS complex 130 ms or above
  • more than three antihypertensive agents in use
  • treatment with digoxin or agents from Vaughan-Williams classes Ic, III või IV
  • frequent high atrial rate episodes
  • coronary artery disease
  • secondary hypertension
  • resistant hypertension
  • orthostatic hypotension
  • heart failure with decreased or preserved left ventricular ejection fraction
  • implantable cardioverter-defibrillator or cardiac resynchronization therapy
  • significant valvular heart disease
  • significant congenital heart disease
  • body mass index ≥35 kg/m2
  • type I diabetes
  • type II diabetes with cardiovascular complications or on insulin therapy
  • other significant endocrine disease
  • history of cerebrovascular attack
  • carotid artery disease
  • lower extremity arterial disease
  • severe chronic obstructive pulmonary disease
  • severe asthma
  • severe sleep apnea
  • interstitial pulmonary disease
  • inhaled beta adrenergic agonist therapy
  • active cancer treatment
  • central nervous system degenerative disease
  • systemic connective tissue disease
  • abnormal TSH at present
  • glomerular filtration rate ≤30 ml/min/m2
  • hemoglobin <100 g/L (female), <110 g/L (male)
  • hepatic dysfunction
  • alcohol abuse
  • pregnancy or breastfeeding
  • no health insurance provided by Estonian Health Insurance Fund
  • withdrawal of informed consent
  • loss of contact with a subject during study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Slow-Fast

    Fast-Slow

    Arm Description

    Outcomes

    Primary Outcome Measures

    systolic blood pressure amplification change

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2020
    Last Updated
    March 13, 2020
    Sponsor
    Tartu University Hospital
    Collaborators
    North Estonia Medical Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04309175
    Brief Title
    Long-term Atrial Pacing and Central Blood Pressure
    Official Title
    Effect of Long-term Atrial Pacing on Central Blood Pressure in Permanently Paced Sick Sinus Syndrome Patients With Primary Arterial Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tartu University Hospital
    Collaborators
    North Estonia Medical Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are paced long-term at a slower vs faster heart rate

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Pressure
    Keywords
    central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Slow-Fast
    Arm Type
    Experimental
    Arm Title
    Fast-Slow
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    base rate programming of a permanent cardiac pacemaker
    Intervention Description
    Base rate of a subject's pacemaker is set to a slower, and after wash-out, to a faster pacing rate (Slow-Fast Arm) or to a faster, and after wash-out, to a slower pacing rate (Fast-Slow Arm)
    Primary Outcome Measure Information:
    Title
    systolic blood pressure amplification change
    Time Frame
    two months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18-80 years sick sinus syndrome permanent cardiac pacemaker with right atrial and right ventricular leads at least 3 months from implantation sinus rhythm percentage of atrial pacing at or above 80% since last interrogation percentage of ventricular pacing at or below 3% since last interrogation primary arterial hypertension antihypertensive drug treatment mean office brachial blood pressure below 140/90 mmHg mean home brachial blood pressure below 135/85 mmHg ability to understand and follow study protocol signed informed consent form Exclusion Criteria: inclusion criteria not fulfilled violation of study protocol by subject, investigator or third part high quality central hemodynamic measurements cannot be perfomed inter-arm difference in brachial systolic blood pressure 15 mmHg or above intrinsic QRS complex 130 ms or above more than three antihypertensive agents in use treatment with digoxin or agents from Vaughan-Williams classes Ic, III või IV frequent high atrial rate episodes coronary artery disease secondary hypertension resistant hypertension orthostatic hypotension heart failure with decreased or preserved left ventricular ejection fraction implantable cardioverter-defibrillator or cardiac resynchronization therapy significant valvular heart disease significant congenital heart disease body mass index ≥35 kg/m2 type I diabetes type II diabetes with cardiovascular complications or on insulin therapy other significant endocrine disease history of cerebrovascular attack carotid artery disease lower extremity arterial disease severe chronic obstructive pulmonary disease severe asthma severe sleep apnea interstitial pulmonary disease inhaled beta adrenergic agonist therapy active cancer treatment central nervous system degenerative disease systemic connective tissue disease abnormal TSH at present glomerular filtration rate ≤30 ml/min/m2 hemoglobin <100 g/L (female), <110 g/L (male) hepatic dysfunction alcohol abuse pregnancy or breastfeeding no health insurance provided by Estonian Health Insurance Fund withdrawal of informed consent loss of contact with a subject during study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Priit Kampus, Dr
    Phone
    +3725200193
    Email
    priit.kampus@regionaalhaigla.ee

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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