Atrial FibrillationPhase 4NCT02734355

Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

A Phase 4 study testing Telmisartan 80 mg and amlodipine 5 mg in people with Atrial Fibrillation, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages Up to 75 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Telmisartan 80 mg and amlodipine 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: No sites listed yet
Study dates: Nov 2015to Feb 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

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.

Read the 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.

Conditions: Atrial Fibrillation
Being tested: Telmisartan 80 mg and amlodipine 5 mg, Placebo (for telmisartan and amlodipine)
Keywords: atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telmisartan 80 mg and amlodipine 5 mgDrug
Also called Twynsta
Placebo (for telmisartan and amlodipine)Drug
Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet

Study groups in NCT02734355
Study group	Role	What they receive
Therapy	Active comparator	Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days Receives: 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 Receives: Drug: Placebo (for telmisartan and amlodipine)

What is being measured

The primary outcome is the main question the study is designed to answer.

Passive Emptying of Left Atrium
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Measured: 7 days
Active Emptying of Left Atrium
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Measured: 7 days
Left Atrial Reservoir Function
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Measured: 7 days
Diastolic Function
E/A ratio of transmitral flow
Measured: 7 days
Isovolumic Relaxation
Left ventricular isovolumic relaxation time (IVRT, ms).
Measured: 7 days
Pulmonary Vein Flow Emptying
S/D ratio of right superior pulmonary vein flow
Measured: 7 days
Retrograde Flow in Pulmonary Veins
Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)
Measured: 7 days
Left Atrial Contractility
Left atrial active emptying fraction (LAAEF, %)
Measured: 7 days
Left Atrial Dimensions
Left atrial antero-posterior diameter (LAD, cm)
Measured: 7 days
Left Atrial Pressure Load
Mean left atrial pressure (MLAP, mm Hg).
Measured: 7 days
Pulmonary Circulation Pressure Load
Right ventricular systolic pressure (RVSP, mm Hg).
Measured: 7 days

Secondary outcomes (2)

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).
Measured: 7 days
Exercise Tolerance
six-minute walk distance in meters
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Feb 2016

First posted12 Apr 2016 (estimated)
Study startNov 2015
Primary completionJan 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02734355
Sponsor's protocol ID: 0546-2015-0013
Status last verified: Feb 2017
First submitted: 30 Mar 2016
Last updated: 22 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25541269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Upstream-therapy by Telmisartan and Amlodipine Combination for Improvement of Left Atrial Mechanical Function After Pulmonary Vein Antrum Isolation
ClinicalTrials.gov ID: NCT02734355
Acronym / sponsor ID: 0546-2015-0013
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, catheter ablation, left atrium, mechanical function, contractility
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
Study start: Nov 2015
Primary completion: Jan 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 12 Apr 2016 (estimated)
Results: Posted 22 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Therapy	Active comparator	Drug: Telmisartan 80 mg and amlodipine 5 mgTelmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
Placebo	Placebo comparator	Drug: Placebo (for telmisartan and amlodipine)Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days

Who may qualify

Ages: Up to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telmisartan 80 mg and amlodipine 5 mgAlso: Twynsta	Drug	Therapy
Placebo (for telmisartan and amlodipine)Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet	Drug	Placebo

Primary outcome

Passive Emptying of Left Atrium
Time frame: 7 days
Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).
Active Emptying of Left Atrium
Time frame: 7 days
Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).
Left Atrial Reservoir Function
Time frame: 7 days
Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.
Diastolic Function
Time frame: 7 days
E/A ratio of transmitral flow
Isovolumic Relaxation
Time frame: 7 days
Left ventricular isovolumic relaxation time (IVRT, ms).
Pulmonary Vein Flow Emptying
Time frame: 7 days
S/D ratio of right superior pulmonary vein flow
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)
Left Atrial Contractility
Time frame: 7 days
Left atrial active emptying fraction (LAAEF, %)
Left Atrial Dimensions
Time frame: 7 days
Left atrial antero-posterior diameter (LAD, cm)
Left Atrial Pressure Load
Time frame: 7 days
Mean left atrial pressure (MLAP, mm Hg).
Pulmonary Circulation Pressure Load
Time frame: 7 days
Right ventricular systolic pressure (RVSP, mm Hg).

2 secondary outcomes

Quality of Life
Time frame: 7 days
Exercise Tolerance
Time frame: 7 days

Results and safety

Results posted to the registry on 22 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapy	34	34
Placebo	30	30

Primary outcome: Passive Emptying of Left Atrium

Time frame: 7 days. Mean (Standard Deviation). Unit: cm

Measure	Therapy n = 34	Placebo n = 30
Value	14.7 (4.4)	20.9 (5.2)

Primary outcome: Active Emptying of Left Atrium

Time frame: 7 days. Mean (Standard Deviation). Unit: cm

Measure	Therapy n = 34	Placebo n = 30
Value	7.4 (2.6)	5.4 (1.3)

Primary outcome: Left Atrial Reservoir Function

Time frame: 7 days. Mean (Standard Deviation). Unit: cm

Measure	Therapy n = 34	Placebo n = 30
Value	19.1 (3.5)	13.3 (3.2)

Primary outcome: Diastolic Function

Time frame: 7 days. Mean (Standard Deviation). Unit: ratio

Measure	Therapy n = 34	Placebo n = 30
Value	1.62 (0.35)	2.64 (0.63)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapy	0 of 34 (0%)	3 of 34 (8.8%)	Not reported
Placebo	0 of 30 (0%)	2 of 30 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25541269Mamchur 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.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yevgeny V Grigoriev, M.D., Ph.D. study chair

Research Institute for Complex Problems of Cardiovascular Diseases

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan 80 mg and amlodipine 5 mg in people with Atrial Fibrillation, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Passive Emptying of Left Atrium (time frame: 7 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734355, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.