Phase 4 N=64 Randomized Single-blind Prevention

Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02734355 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Passive Emptying of Left Atrium — 14.7; 20.9 cm

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Telmisartan 80 mg and amlodipine 5 mg (Drug); Placebo (for telmisartan and amlodipine) (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Passive Emptying of Left Atrium	14.7; 20.9	—
PRIMARY Active Emptying of Left Atrium	7.4; 5.4	—
PRIMARY Left Atrial Reservoir Function	19.1; 13.3	—
PRIMARY Diastolic Function	1.62; 2.64	—
PRIMARY Isovolumic Relaxation	117; 98	—
PRIMARY Pulmonary Vein Flow Emptying	1.3; 1.46	—
PRIMARY Retrograde Flow in Pulmonary Veins	4.1; 1.5	—
PRIMARY Left Atrial Contractility	40; 31.6	—
PRIMARY Left Atrial Dimensions	3.9; 4.1	—
PRIMARY Left Atrial Pressure Load	9; 13.8	—
PRIMARY Pulmonary Circulation Pressure Load	16.7; 31.6	—
SECONDARY Quality of Life	92; 85	—
SECONDARY Exercise Tolerance	403; 345	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02734355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.