NCT04484688

Brief Summary

The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of bisoprolol/perindopril in patients with permanent atrial fibrillation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 21, 2020

Last Update Submit

July 21, 2020

Conditions

Patient Participation

Outcome Measures

Primary Outcomes (1)

  • 12-ecg and echocardiography evaluation after 1 month treatment

    1 month

Interventions

perindopril-bisoprololDRUG

outpatients with permanent atrial fibrillation and with preserved ejection fraction

Also known as: prestilol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with AF and normal EF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aversi Clinic

Tbilisi, Georgia

Location

Aversi Clinic

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,FESC

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 23, 2020

Study Start

August 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

GE(2)