NCT05936164

Brief Summary

Atrial fibrillation is the most common sustained cardiac arrhythmia (rhythm abnormality) encountered in clinical practice. It contributes significantly to the risk of cardiac symptoms, hospital admissions, cardiovascular related morbidity and mortality and increased healthcare cost. AF has significant impact on healthcare cost. The major drivers of the cost are hospitalisations, stroke and loss of productivity. Globally AF accounts for less than 1% of all deaths. However, because it co-exists with other conditions, it contributes to worse prognosis compared to persons who do not have AF. New onset AF in HF patients may be associated with particularly poor prognosis. Most of the published data and current knowledge on AF epidemiology are based on studies in Europe and North America. The information obtainable from previous studies in sub-Saharan Africa is limited. Many of the studies were retrospective. There is also paucity of information on burden of AF (both in hospital and community), clinical profile and outcome of AF in Nigeria in particular and Africa in general. The primary objective of this study is to determine the clinical characteristics, outcome as well as cost genetic features of AF in Nigeria. The project will provide information on: i. Hospital and community burden of AF in Nigeria; ii. Clinical features, mode of presentation and risk factors for AF; iii. Provide data on AF related outcomes as well as prognostic factors.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Oct 2023

Longer than P75 for all trials

Status
not yet recruiting

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

Study Progress50%
Oct 2023Dec 2028

First Submitted

Initial submission to the registry

June 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

June 29, 2023

Last Update Submit

June 29, 2023

Conditions

Keywords

Atrial fibrillation, arrhythmias, heart failure

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    All deaths

    12 months

Secondary Outcomes (3)

  • Hospitalisation

    At 12 months

  • Stroke

    12 months

  • Any other thromboembolic events

    12 months

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are eligible to participate if they are 15 years and above and have 12-lead ECG features of atrial fibrillation

You may qualify if:

  • All cases of confirmed atrial fibrillation

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 7, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

July 7, 2023

Record last verified: 2023-06