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Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telmisartan 80 mg and amlodipine 5 mg
Placebo (for telmisartan and amlodipine)
Sponsored by
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal atrial fibrillation;
  • Ineffective therapy by at least one of the class I or III antiarrhythmic drugs;
  • Left atrial diameter 5 cm or less;
  • Estimated catheter radiofrequency pulmonary vein antrum isolation;
  • Signed informed consent.

Exclusion Criteria:

  • Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or enoxaparin;
  • Left atrial thrombosis;
  • Age greater than 75 years;
  • Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic conditions;
  • Malignant growth in the hematogenic dissemination stage.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Therapy

    Placebo

    Arm Description

    Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days

    Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days

    Outcomes

    Primary Outcome Measures

    Passive Emptying of Left Atrium
    Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
    Active Emptying of Left Atrium
    Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
    Left Atrial Reservoir Function
    Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
    Diastolic Function
    E/A ratio of transmitral flow
    Isovolumic Relaxation
    Left ventricular isovolumic relaxation time (IVRT, ms).
    Pulmonary Vein Flow Emptying
    S/D ratio of right superior pulmonary vein flow
    Retrograde Flow in Pulmonary Veins
    Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
    Left Atrial Contractility
    Left atrial active emptying fraction (LAAEF, %)
    Left Atrial Dimensions
    Left atrial antero-posterior diameter (LAD, cm)
    Left Atrial Pressure Load
    Mean left atrial pressure (MLAP, mm Hg).
    Pulmonary Circulation Pressure Load
    Right ventricular systolic pressure (RVSP, mm Hg).

    Secondary Outcome Measures

    Quality of Life
    The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).
    Exercise Tolerance
    six-minute walk distance in meters

    Full Information

    First Posted
    March 30, 2016
    Last Updated
    February 1, 2017
    Sponsor
    Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02734355
    Brief Title
    Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation
    Official Title
    Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Research Institute for Complex Problems of Cardiovascular Diseases, Russia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the study was to estimate the efficacy of telmisartan and amlodipine combination on the restoration of left atrial mechanical function after atrial fibrillation catheter ablation.
    Detailed Description
    64 candidates to atrial fibrillation ablation were included in the study. Patients were randomly assigned to telmisartan/amlodipine combination in dose 80/5 mg (group I, n=34) or placebo (group II, n=30) taking daily for up to one week. Echocardiography was performed before the procedure, immediately after it, and after a week of therapy. The six-minute walk test and SF-36 questionnaire results were evaluated a day before the procedure and after a week of the therapy. The left ventricular end-diastolic pressure was invasively measured after transseptal puncture and before left atrial sheath removal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapy
    Arm Type
    Active Comparator
    Arm Description
    Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Telmisartan 80 mg and amlodipine 5 mg
    Other Intervention Name(s)
    Twynsta
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (for telmisartan and amlodipine)
    Intervention Description
    Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
    Primary Outcome Measure Information:
    Title
    Passive Emptying of Left Atrium
    Description
    Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
    Time Frame
    7 days
    Title
    Active Emptying of Left Atrium
    Description
    Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
    Time Frame
    7 days
    Title
    Left Atrial Reservoir Function
    Description
    Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
    Time Frame
    7 days
    Title
    Diastolic Function
    Description
    E/A ratio of transmitral flow
    Time Frame
    7 days
    Title
    Isovolumic Relaxation
    Description
    Left ventricular isovolumic relaxation time (IVRT, ms).
    Time Frame
    7 days
    Title
    Pulmonary Vein Flow Emptying
    Description
    S/D ratio of right superior pulmonary vein flow
    Time Frame
    7 days
    Title
    Retrograde Flow in Pulmonary Veins
    Description
    Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
    Time Frame
    7 days
    Title
    Left Atrial Contractility
    Description
    Left atrial active emptying fraction (LAAEF, %)
    Time Frame
    7 days
    Title
    Left Atrial Dimensions
    Description
    Left atrial antero-posterior diameter (LAD, cm)
    Time Frame
    7 days
    Title
    Left Atrial Pressure Load
    Description
    Mean left atrial pressure (MLAP, mm Hg).
    Time Frame
    7 days
    Title
    Pulmonary Circulation Pressure Load
    Description
    Right ventricular systolic pressure (RVSP, mm Hg).
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Quality of Life
    Description
    The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).
    Time Frame
    7 days
    Title
    Exercise Tolerance
    Description
    six-minute walk distance in meters
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal atrial fibrillation; Ineffective therapy by at least one of the class I or III antiarrhythmic drugs; Left atrial diameter 5 cm or less; Estimated catheter radiofrequency pulmonary vein antrum isolation; Signed informed consent. Exclusion Criteria: Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or enoxaparin; Left atrial thrombosis; Age greater than 75 years; Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic conditions; Malignant growth in the hematogenic dissemination stage.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yevgeny V Grigoriev, M.D., Ph.D.
    Organizational Affiliation
    Research Institute for Complex Problems of Cardiovascular Diseases
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25541269
    Citation
    Mamchur S, Mamchur I, Khomenko E, Kokov A, Bokhan N, Sherbinina D. Mechanical function of left atrium and pulmonary vein sleeves before and after their antrum isolation. Medicina (Kaunas). 2014;50(6):353-9. doi: 10.1016/j.medici.2014.11.008. Epub 2014 Nov 28.
    Results Reference
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    Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

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