Title

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

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    amlodipine telmisartan ...
  • Study Participants

    64
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.
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.
Study Started
Nov 30
2015
Primary Completion
Jan 31
2016
Study Completion
Feb 29
2016
Results Posted
Mar 22
2017
Last Update
Mar 22
2017

Drug Telmisartan 80 mg and amlodipine 5 mg

  • Other names: Twynsta

Drug Placebo (for telmisartan and amlodipine)

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

Therapy Active Comparator

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

Placebo Placebo Comparator

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

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.

Summary

Therapy

Placebo

All Events

Event Type Organ System Event Term Therapy Placebo

Passive Emptying of Left Atrium

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

Therapy

14.7
cm (Mean)
Standard Deviation: 4.4

Placebo

20.9
cm (Mean)
Standard Deviation: 5.2

Active Emptying of Left Atrium

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

Therapy

7.4
cm (Mean)
Standard Deviation: 2.6

Placebo

5.4
cm (Mean)
Standard Deviation: 1.3

Left Atrial Reservoir Function

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

Therapy

19.1
cm (Mean)
Standard Deviation: 3.5

Placebo

13.3
cm (Mean)
Standard Deviation: 3.2

Diastolic Function

E/A ratio of transmitral flow

Therapy

1.62
ratio (Mean)
Standard Deviation: 0.35

Placebo

2.64
ratio (Mean)
Standard Deviation: 0.63

Isovolumic Relaxation

Left ventricular isovolumic relaxation time (IVRT, ms).

Therapy

117.0
ms (Mean)
Standard Deviation: 19

Placebo

98.0
ms (Mean)
Standard Deviation: 10

Pulmonary Vein Flow Emptying

S/D ratio of right superior pulmonary vein flow

Therapy

1.3
ratio (Mean)
Standard Deviation: 0.39

Placebo

1.46
ratio (Mean)
Standard Deviation: 0.37

Retrograde Flow in Pulmonary Veins

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

Therapy

4.1
cm (Mean)
Standard Deviation: 1.4

Placebo

1.5
cm (Mean)
Standard Deviation: 0.5

Left Atrial Contractility

Left atrial active emptying fraction (LAAEF, %)

Therapy

40.0
percentage of LA maximum volume (Mean)
Standard Deviation: 6.7

Placebo

31.6
percentage of LA maximum volume (Mean)
Standard Deviation: 6.7

Left Atrial Dimensions

Left atrial antero-posterior diameter (LAD, cm)

Therapy

3.9
cm (Mean)
Standard Deviation: 0.3

Placebo

4.1
cm (Mean)
Standard Deviation: 0.6

Left Atrial Pressure Load

Mean left atrial pressure (MLAP, mm Hg).

Therapy

9.0
mm Hg (Mean)
Standard Deviation: 3.1

Placebo

13.8
mm Hg (Mean)
Standard Deviation: 2.9

Pulmonary Circulation Pressure Load

Right ventricular systolic pressure (RVSP, mm Hg).

Therapy

16.7
mm Hg (Mean)
Standard Deviation: 9.6

Placebo

31.6
mm Hg (Mean)
Standard Deviation: 14.4

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).

Therapy

92.0
units on a scale (Mean)
Standard Deviation: 4

Placebo

85.0
units on a scale (Mean)
Standard Deviation: 5

Exercise Tolerance

six-minute walk distance in meters

Therapy

403.0
m (Mean)
Standard Deviation: 27

Placebo

345.0
m (Mean)
Standard Deviation: 25

Total

64
Participants

Age, Continuous

53.1
years (Mean)
Standard Deviation: 6.7

Region of Enrollment

Sex: Female, Male

Overall Study

Therapy

Placebo