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Risk Profile for Patients With Atrial Fibrillation

NCT ID: NCT01510210

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2025-03-31

Brief Summary

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The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.

Detailed Description

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Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Short-lasting symptomatic paroxysmal or persistent AF;
* Rhythm control strategy is preferred;
* No contra-indication for oral anticoagulation;
* Age \> 18 years;
* Written informed consent

Exclusion Criteria

* Total history of heart failure and/ or of severe valvular disease \> 3 years;
* Severe valvular disease;
* Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
* Post-operative AF.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands Heart Foundation

OTHER

Sponsor Role collaborator

I.C. Van Gelder

OTHER

Sponsor Role lead

Responsible Party

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I.C. Van Gelder

MD. PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Harry Crijns, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Isabelle C Van Gelder, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, Jan van Zonneveld A, Erkuner O, Bayon MA, Schmidt AS, Luermans JGLM, Crijns HJGM, Van Gelder IC, Rienstra M. Different circulating biomarkers in women and men with paroxysmal atrial fibrillation: results from the AF-RISK and RACE V studies. Europace. 2022 Feb 2;24(2):193-201. doi: 10.1093/europace/euab179.

Reference Type DERIVED
PMID: 34329401 (View on PubMed)

Nguyen BO, Meems LMG, van Faassen M, Crijns HJGM, van Gelder IC, Kuipers F, Rienstra M. Gut-microbe derived TMAO and its association with more progressed forms of AF: Results from the AF-RISK study. Int J Cardiol Heart Vasc. 2021 May 24;34:100798. doi: 10.1016/j.ijcha.2021.100798. eCollection 2021 Jun.

Reference Type DERIVED
PMID: 34095450 (View on PubMed)

De With RR, Marcos EG, Dudink EAMP, Spronk HM, Crijns HJGM, Rienstra M, Van Gelder IC. Atrial fibrillation progression risk factors and associated cardiovascular outcome in well-phenotyped patients: data from the AF-RISK study. Europace. 2020 Mar 1;22(3):352-360. doi: 10.1093/europace/euz339.

Reference Type DERIVED
PMID: 31865391 (View on PubMed)

Other Identifiers

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NHS2010B233

Identifier Type: -

Identifier Source: org_study_id