Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

NCT02734355 | Completed Phase 4 Results

• 1 other identifier: 0546-2015-0013
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; left atrium; mechanical function; contractility

Outcome Measures

Primary Outcomes (11)

• Passive Emptying of Left Atrium

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

  7 days

• Active Emptying of Left Atrium

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

  7 days

• Left Atrial Reservoir Function

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

  7 days

• Diastolic Function

  E/A ratio of transmitral flow

  7 days

• Isovolumic Relaxation

  Left ventricular isovolumic relaxation time (IVRT, ms).

  7 days

• Pulmonary Vein Flow Emptying

  S/D ratio of right superior pulmonary vein flow

  7 days

• Retrograde Flow in Pulmonary Veins

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

  7 days

• Left Atrial Contractility

  Left atrial active emptying fraction (LAAEF, %)

  7 days

• Left Atrial Dimensions

  Left atrial antero-posterior diameter (LAD, cm)

  7 days

• Left Atrial Pressure Load

  Mean left atrial pressure (MLAP, mm Hg).

  7 days

• Pulmonary Circulation Pressure Load

  Right ventricular systolic pressure (RVSP, mm Hg).

  7 days

Secondary Outcomes (2)

• Quality of Life

  7 days

• Exercise Tolerance

  7 days

Study Arms (2)

Therapy

ACTIVE COMPARATOR

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

Drug: Telmisartan 80 mg and amlodipine 5 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (for telmisartan and amlodipine)

Interventions

Telmisartan 80 mg and amlodipine 5 mg DRUG

Also known as: Twynsta

Therapy

Placebo (for telmisartan and amlodipine) DRUG

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

Placebo

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Complex Problems of Cardiovascular Diseases, Russia: lead

Related Publications (1)

• 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.

  PMID: 25541269 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Telmisartan; Amlodipine; telmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Sergey Mamchur
• Organization: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

reception@kemcardio.ru

+73842643308

Study Officials

• Yevgeny V Grigoriev, M.D., Ph.D.

  Research Institute for Complex Problems of Cardiovascular Diseases

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Cardiovascular Disorders Diagnosis

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 12, 2016
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 22, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share