NCT05080712

Brief Summary

The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress78%
Sep 2021Dec 2027

First Submitted

Initial submission to the registry

September 23, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 25, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

6.2 years

First QC Date

September 23, 2021

Last Update Submit

May 22, 2024

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationprogressionleft atrial function

Outcome Measures

Primary Outcomes (1)

  • Development of atrial fibrillation burden

    Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly

    change from baseline at 5 years

Secondary Outcomes (8)

  • Development of humoral measures of hemodynamic status

    Change from baseline at 5 years

  • Development of atrial electrocardiographic status

    Change from baseline at 5 years

  • Development of supraventricular ectopies

    Change from baseline at 5 years

  • Development of atrial fibrillation incident

    Change from baseline at 5 years

  • Development of echocardiographic status

    Change from baseline at 5 years

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with new onset atrial fibrillation within 12 months from inclusion

You may qualify if:

  • Atrial fibrillation

You may not qualify if:

  • Duration of atrial fibrillation over one year.
  • Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationDisease Progression

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Piotr Sobocinski Doliwa, MD, PhD

    Karolinska Institutet Danderyds University Hospital

    STUDY CHAIR

Central Study Contacts

Piotr Sobocinski Doliwa, M.D. Ph.D.

CONTACT

+46812357556piotr.sobocinski-doliwa@sll.se

Johan Engdahl, MD PhD

CONTACT

johan.engdahl@sll.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 18, 2021

Study Start

September 25, 2021

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

December 20, 2027

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

SE(1)