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Completed

NCT Number: NCT02734355

Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

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.

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telmisartan 80 mg and amlodipine 5 mg

Drug

Other names: Twynsta

Placebo (for telmisartan and amlodipine)

Drug

Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet

Primary outcomes

  1. Passive Emptying of Left Atrium

    Time frame: 7 days

    Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).

  2. Active Emptying of Left Atrium

    Time frame: 7 days

    Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).

  3. Left Atrial Reservoir Function

    Time frame: 7 days

    Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.

  4. Diastolic Function

    Time frame: 7 days

    E/A ratio of transmitral flow

  5. Isovolumic Relaxation

    Time frame: 7 days

    Left ventricular isovolumic relaxation time (IVRT, ms).

  6. Pulmonary Vein Flow Emptying

    Time frame: 7 days

    S/D ratio of right superior pulmonary vein flow

  7. Retrograde Flow in Pulmonary Veins

    Time frame: 7 days

    Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)

  8. Left Atrial Contractility

    Time frame: 7 days

    Left atrial active emptying fraction (LAAEF, %)

  9. Left Atrial Dimensions

    Time frame: 7 days

    Left atrial antero-posterior diameter (LAD, cm)

  10. Left Atrial Pressure Load

    Time frame: 7 days

    Mean left atrial pressure (MLAP, mm Hg).

  11. Pulmonary Circulation Pressure Load

    Time frame: 7 days

    Right ventricular systolic pressure (RVSP, mm Hg).

Secondary outcomes

  1. Quality of Life

    Time frame: 7 days

    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).

  2. Exercise Tolerance

    Time frame: 7 days

    six-minute walk distance in meters

Sponsors and collaborators

Lead sponsor

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Other

Registry information

Official study title

Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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