Atrial FibrillationRACE VNCT02726698
Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Medical Center Groningen at 9 sites in Netherlands.
Trial summary
The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 750 participants
- Where
- 9 sitesNetherlands
- Study dates
- Jul 2016to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with paroxysmal (self-terminating) AF in the cardiology outpatient department, first (heart) aid and pacemaker clinic.
Who may be able to join
- New onset or history of paroxysmal, self-terminating AF documented as:
- AF on ECG or Holter-recording or loop recorder
- Subclinical AF detected in implantable cardiac devices (atrial read > 190 beats per minute, lasting > 6 minutes).
- Prior history of self-terminating AF is allowed;
- Able and willing to sign informed consent for the registry;
- Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED);
Show all 10Show fewer
- In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping):
- CHA2DS2-VASc score ≤5 (history of Congestive heart failure, Hypertension, Age ≥ 75 years (doubled), Diabetes mellitus,Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-75 years, female Sex);
- No other indication for oral anticoagulation (e.g. mechanical valve prosthesis);
- Patient is willing to temporarily stop oral anticoagulation drugs (OAC).
Who cannot join
- Non-self-terminating, persistent AF;
- Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);
- Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study);
- On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year;
- Expected to start with amiodarone;
- Pregnancy;
- Life expectancy of less than 2.5 years.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Amsterdam University Medical Center - AMC
Amsterdam
Amsterdam University Medical Center - VU
Amsterdam
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
University Medical Center Groningen
Groningen, 9713 GZ
Martini Hospital
Groningen, 9728 NT
Ommelander Ziekenhuis
Groningen
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Laurentius Hospital
Roermond
Isala
Zwolle
About this study
Official title: Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation - An Observational Exploratory Study on Pathophysiological Mechanisms of AF Progression and on the Role of LinQ/CareLink Guided Patient Tailored Therapy in Patients With Atrial Fibrillation
The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of AF burden
Measured: 2.5 years
Secondary outcomes (2)
Major Adverse Cardiac and Cerebrovascular Events
Measured: 2.5 years
Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2024
- Study completionOct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, I.C. Van Gelder, University Medical Center Groningen
- Investigators
- Harry JGM Crijns, MD, PhD, Principal investigator, Maastricht University Medical CenterIsabelle C van Gelder, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726698
- Sponsor's protocol ID
- NL53561.042.16
- Acronym
- RACE V
- Status last verified
- Dec 2024
- First submitted
- 17 Mar 2016
- Last updated
- 6 Dec 2024
- Results posted
- No
Publications
Frausing MHJP, Rienstra M, Kronborg MB, De Melis M, Schotten U, Nielsen JC, Tieleman R, Crijns HJ, Van Gelder IC, Samuel M. Association between circulating biomarkers and atrial fibrillation burden in patients with paroxysmal atrial fibrillation: a subanalysis of the RACE V study. Open Heart. 2025 Sep 30;12(2):e003433. doi: 10.1136/openhrt-2025-003433.
PubMed 41033708van Deutekom C, van de Lande ME, Rama R, Nguyen BO, Tieleman RG, Weberndorfer V, Hemels MEW, de Melis M, Schotten U, Linz D, Crijns HJGM, van Gelder IC, Rienstra M; RACE V Investigators. Multimorbidity Is Associated With Symptom Severity and Disease Progression in Patients with Paroxysmal Atrial Fibrillation-Data From the RACE V Study. J Am Heart Assoc. 2025 Mar 4;14(5):e034514. doi: 10.1161/JAHA.123.034514. Epub 2025 Feb 26.
PubMed 40008502Koldenhof T, Van Gelder IC, van de Lande ME, Al-Jazairi MIH, Tieleman RG, Rienstra M. High heart rates during paroxysmal atrial fibrillation: continuous rhythm monitoring data of the RACE V study. Heart. 2024 Oct 10;110(21):1250-1253. doi: 10.1136/heartjnl-2024-324376.
PubMed 39168591Frausing MHJP, Van De Lande M, Linz D, Crijns HJGM, Tieleman RG, Hemels MEW, De Melis M, Schotten U, Kronborg MB, Nielsen JC, Van Gelder I, Rienstra M. Healthcare utilisation and quality of life according to atrial fibrillation burden, episode frequency and duration. Heart. 2024 Jul 25;110(16):1030-1039. doi: 10.1136/heartjnl-2024-324016.
PubMed 38944418van de Lande ME, Rama RS, Koldenhof T, Arita VA, Nguyen BO, van Deutekom C, Weberndorfer V, Crijns HJGM, Hemels MEW, Tieleman RG, de Melis M, Schotten U, Linz D, Van Gelder IC, Rienstra M; RACE V Investigators. Time of onset of atrial fibrillation and atrial fibrillation progression data from the RACE V study. Europace. 2023 May 19;25(5):euad058. doi: 10.1093/europace/euad058.
PubMed 36967470Frausing MHJP, Van De Lande ME, Maass AH, Nguyen BO, Hemels MEW, Tieleman RG, Koldenhof T, De Melis M, Linz D, Schotten U, Weberndorfer V, Crijns HJGM, Van Gelder IC, Nielsen JC, Rienstra M. Brady- and tachyarrhythmias detected by continuous rhythm monitoring in paroxysmal atrial fibrillation. Heart. 2023 Aug 11;109(17):1286-1293. doi: 10.1136/heartjnl-2022-322253.
PubMed 36948572Artola Arita V, Van De Lande ME, Khalilian Ekrami N, Nguyen BO, Van Melle JM, Geelhoed B, De With RR, Weberndorfer V, Erkuner O, Hillege H, Linz D, Ten Cate H, Spronk HMH, Koldenhof T, Tieleman RG, Schotten U, Crijns HJGM, Van Gelder IC, Rienstra M. Clinical utility of the 4S-AF scheme in predicting progression of atrial fibrillation: data from the RACE V study. Europace. 2023 Apr 15;25(4):1323-1331. doi: 10.1093/europace/euac268.
PubMed 36857318Nguyen BO, Weberndorfer V, Crijns HJ, Geelhoed B, Ten Cate H, Spronk H, Kroon A, De With R, Al-Jazairi M, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, Luermans J, de Groot J, Allaart CP, Elvan A, De Melis M, Scheerder C, van Zonneveld AJ, Schotten U, Linz D, Van Gelder I, Rienstra M. Prevalence and determinants of atrial fibrillation progression in paroxysmal atrial fibrillation. Heart. 2022 Jul 20;109(3):186-94. doi: 10.1136/heartjnl-2022-321027. Online ahead of print.
PubMed 35858774De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, van Zonneveld AJ, 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.
PubMed 34329401De With RR, Erkuner O, Rienstra M, Nguyen BO, Korver FWJ, Linz D, Cate Ten H, Spronk H, Kroon AA, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, de Groot JR, Elvan A, de Melis M, Scheerder COS, Al-Jazairi MIH, Schotten U, Luermans JGLM, Crijns HJGM, Van Gelder IC; RACE V Investigators. Temporal patterns and short-term progression of paroxysmal atrial fibrillation: data from RACE V. Europace. 2020 Aug 1;22(8):1162-1172. doi: 10.1093/europace/euaa123.
PubMed 32642768
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation - An Observational Exploratory Study on Pathophysiological Mechanisms of AF Progression and on the Role of LinQ/CareLink Guided Patient Tailored Therapy in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02726698
- Acronym / sponsor ID
- RACE V / NL53561.042.16
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2024 (actual)
- Study completion
- Oct 2024 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal (self-terminating) AF in the cardiology outpatient department, first (heart) aid and pacemaker clinic.
Key inclusion criteria (10 listed)
- New onset or history of paroxysmal, self-terminating AF documented as:
- Prior history of self-terminating AF is allowed;
- Able and willing to sign informed consent for the registry;
- Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED);
- In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping):
Key exclusion criteria (7 listed)
- Non-self-terminating, persistent AF;
- Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);
- Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study);
- On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year;
- Expected to start with amiodarone;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of AF burden
Time frame: 2.5 years
2 secondary outcomes
Major Adverse Cardiac and Cerebrovascular Events
Time frame: 2.5 years
Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system
Time frame: 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41033708Frausing MHJP, Rienstra M, Kronborg MB, De Melis M, Schotten U, Nielsen JC, Tieleman R, Crijns HJ, Van Gelder IC, Samuel M. Association between circulating biomarkers and atrial fibrillation burden in patients with paroxysmal atrial fibrillation: a subanalysis of the RACE V study. Open Heart. 2025 Sep 30;12(2):e003433. doi: 10.1136/openhrt-2025-003433.
- Derived from this study: PubMed 40008502van Deutekom C, van de Lande ME, Rama R, Nguyen BO, Tieleman RG, Weberndorfer V, Hemels MEW, de Melis M, Schotten U, Linz D, Crijns HJGM, van Gelder IC, Rienstra M; RACE V Investigators. Multimorbidity Is Associated With Symptom Severity and Disease Progression in Patients with Paroxysmal Atrial Fibrillation-Data From the RACE V Study. J Am Heart Assoc. 2025 Mar 4;14(5):e034514. doi: 10.1161/JAHA.123.034514. Epub 2025 Feb 26.
- Derived from this study: PubMed 39168591Koldenhof T, Van Gelder IC, van de Lande ME, Al-Jazairi MIH, Tieleman RG, Rienstra M. High heart rates during paroxysmal atrial fibrillation: continuous rhythm monitoring data of the RACE V study. Heart. 2024 Oct 10;110(21):1250-1253. doi: 10.1136/heartjnl-2024-324376.
- Derived from this study: PubMed 38944418Frausing MHJP, Van De Lande M, Linz D, Crijns HJGM, Tieleman RG, Hemels MEW, De Melis M, Schotten U, Kronborg MB, Nielsen JC, Van Gelder I, Rienstra M. Healthcare utilisation and quality of life according to atrial fibrillation burden, episode frequency and duration. Heart. 2024 Jul 25;110(16):1030-1039. doi: 10.1136/heartjnl-2024-324016.
- Derived from this study: PubMed 36967470van de Lande ME, Rama RS, Koldenhof T, Arita VA, Nguyen BO, van Deutekom C, Weberndorfer V, Crijns HJGM, Hemels MEW, Tieleman RG, de Melis M, Schotten U, Linz D, Van Gelder IC, Rienstra M; RACE V Investigators. Time of onset of atrial fibrillation and atrial fibrillation progression data from the RACE V study. Europace. 2023 May 19;25(5):euad058. doi: 10.1093/europace/euad058.
- Derived from this study: PubMed 36948572Frausing MHJP, Van De Lande ME, Maass AH, Nguyen BO, Hemels MEW, Tieleman RG, Koldenhof T, De Melis M, Linz D, Schotten U, Weberndorfer V, Crijns HJGM, Van Gelder IC, Nielsen JC, Rienstra M. Brady- and tachyarrhythmias detected by continuous rhythm monitoring in paroxysmal atrial fibrillation. Heart. 2023 Aug 11;109(17):1286-1293. doi: 10.1136/heartjnl-2022-322253.
- Derived from this study: PubMed 36857318Artola Arita V, Van De Lande ME, Khalilian Ekrami N, Nguyen BO, Van Melle JM, Geelhoed B, De With RR, Weberndorfer V, Erkuner O, Hillege H, Linz D, Ten Cate H, Spronk HMH, Koldenhof T, Tieleman RG, Schotten U, Crijns HJGM, Van Gelder IC, Rienstra M. Clinical utility of the 4S-AF scheme in predicting progression of atrial fibrillation: data from the RACE V study. Europace. 2023 Apr 15;25(4):1323-1331. doi: 10.1093/europace/euac268.
- Derived from this study: PubMed 35858774Nguyen BO, Weberndorfer V, Crijns HJ, Geelhoed B, Ten Cate H, Spronk H, Kroon A, De With R, Al-Jazairi M, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, Luermans J, de Groot J, Allaart CP, Elvan A, De Melis M, Scheerder C, van Zonneveld AJ, Schotten U, Linz D, Van Gelder I, Rienstra M. Prevalence and determinants of atrial fibrillation progression in paroxysmal atrial fibrillation. Heart. 2022 Jul 20;109(3):186-94. doi: 10.1136/heartjnl-2022-321027. Online ahead of print.
- Derived from this study: PubMed 34329401De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, van Zonneveld AJ, 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.
- Derived from this study: PubMed 32642768De With RR, Erkuner O, Rienstra M, Nguyen BO, Korver FWJ, Linz D, Cate Ten H, Spronk H, Kroon AA, Maass AH, Blaauw Y, Tieleman RG, Hemels MEW, de Groot JR, Elvan A, de Melis M, Scheerder COS, Al-Jazairi MIH, Schotten U, Luermans JGLM, Crijns HJGM, Van Gelder IC; RACE V Investigators. Temporal patterns and short-term progression of paroxysmal atrial fibrillation: data from RACE V. Europace. 2020 Aug 1;22(8):1162-1172. doi: 10.1093/europace/euaa123.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry JGM Crijns, MD, PhD principal investigator
Maastricht University Medical Center
Isabelle C van Gelder, MD, PhD principal investigator
University Medical Center Groningen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Medical Center Groningen at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of AF burden (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726698, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.