NCT01510210

Brief Summary

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.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

13.9 years

First QC Date

December 28, 2011

Last Update Submit

November 28, 2023

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationArrhythmiaRhythm control

Outcome Measures

Primary Outcomes (1)

  • Success of rhythm control

    (1) \< 1 second AF on end-of-study ECG; (2) \< 30 seconds AF on end-of-study 48-hour Holter recording; (3) no AF on end-of-study 2 weeks Vitaphone ECG-card recording.

    12 month

Secondary Outcomes (8)

  • Time to recurrence of (a)symptomatic AF

    1+3+6+9+12 month

  • Failure of rhythm control, i.e. permanent AF

    1+3+6+9+12 month

  • Risk profiles associated with early versus late AF recurrence

    1month and 12 month

  • Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF

    1+3+6+9+12 month

  • Changes in atrial and ventricular echocardiographic parameters

    1month and 12 month

  • +3 more secondary outcomes

Eligibility Criteria

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

Patients with short-lasting symptomatic paroxysmal or persistent AF

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ Groningen, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 34329401DERIVED

  • 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.

    PMID: 34095450DERIVED

  • 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.

    PMID: 31865391DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma stored at -80 degrees Celcius. If informed consent was obtained, DNA extraction has been performed.

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harry Crijns, MD PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Isabelle C Van Gelder, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD. PhD

Study Record Dates

First Submitted

December 28, 2011

First Posted

January 16, 2012

Study Start

April 1, 2011

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

NL(1)