Progression of Atrial Fibrillation in the Young | NCT05080712

Studies
Progression of Atrial Fibrillation in the Young

NCT05080712

Sponsor

Karolinska Institutet

Status

Recruiting

Last Update Posted

May 23, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2021Actual

Primary Completion Date

Dec 20, 2027Estimated

Completion Date

Dec 20, 2027Estimated

First Submitted Date

Sep 23, 2021

First Submission Date that Met QC Criteria

Oct 4, 2021

First Posted Date

Oct 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2024

Last Update Posted Date

May 23, 2024Actual

Name	Class
Boehringer Ingelheim	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

100 patients with symptomatic Atrial Fibrillation diagnosis are included. Diagnosis is set either at the index visit or within 12 months before inclusion. . The follow up period is 5 years. Patients presenting with AF in connection with acute infection, acute cardiac ischemia, surgery or thyroid disease are excluded. Further, AF patients with cardiomyopathies, known genetic diseases and congenital cardiac abnormalities are also excluded.

At inclusion patients undergo an in-depth interview regarding comorbidities, medication, previous treatments related to the AF diagnosis. In addition, baseline data for weight and height are collected.

In connection to inclusion the patients are asked leave venous bloodwork (Na, K, Creatinine, plasma Glucose and NTproB-Type Natriuretic Peptide). An echocardiographic exam is performed according to a prespecified protocol with special emphasis on the left atrial function and anatomy. This is followed by a continuous ECG recording for 14 days using BioTel ePatch. The ECG patch is later returned to a core facility by mail.

The patients´ are followed for five years and are asked to leave bloodwork and perform a 14-day ECG recording yearly. After these exams, a follow up phone call is placed to the patient aimed at documenting clinical progress related to symptoms, treatment and interventions. After 5 years follow up patients undergo a follow up echocardiographic exam in addition to yearly bloodwork and ECG recording. The patients´ clinical symptoms are treated at the clinician´s discretion according to current guidelines.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Development of humoral measures of hemodynamic status	Change in levels of plasma-N-terminal pro brain natriuretic peptide yearly (ng)	Change from baseline at 5 years
Development of atrial electrocardiographic status

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Atrial fibrillation
Diagnosis of atrial fibrillation within one year of inclusion

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients with new onset atrial fibrillation within 12 months from inclusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Piotr Sobocinski Doliwa, M.D. Ph.D.	Contact	+46812357556		piotr.sobocinski-doliwa@sll.se
Johan Engdahl, MD PhD	Contact			johan.engdahl@sll.se

Overall Officials

Name	Affiliation	Role
Piotr Sobocinski Doliwa, MD, PhD	Karolinska Institutet Danderyds University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danderyd Hospital	Recruiting	Stockholm			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D018450	Disease Progression

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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