Predictive Properties of Myocardial Fibrosis Biomarkers on the Outcome of Atrial Fibrillation Ablation

NCT ID: NCT05179902

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2025-01-31

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia. As an independent predictor of cardiovascular mortality, particularly for stroke, its management is a real public health issue. AF is associated with diabetes, obesity, hypertension, heart failure and, occasionally, hyperthyroidism. Atrial fibrosis is one of the major players in the genesis and maintenance of AF. It has a strong impact on rhythmic prognosis and treatment success.

Currently the AF ablation is the treatment recommended by the European Society of Cardiology (ESC) and by the American Society of Cardiology. The rate of AF recurrence is variable according to the patient characteristics and remains unfortunately today difficult to predict.

Abnormal concentrations of circulating biomarkers reflecting the underlying pathophysiologic mechanisms of myocardial fibrosis could help to identify patients at higher risk of developing AF and/or AF recurrence after ablation. Thus, the development of simple, reliable and valid biological tests of atrial fibrosis would allow the clinicians i) to estimate the potential success of AF ablation; ii) to predict AF recurrence; iv) and to propose a AF personalized therapeutic approach.

The main objective of PROFIB-AF study is to identify, among biological markers (ICTP, PICP, PIIINP, sRAGE, AGE, Galectin 3, sSt2, microRNAs) of myocardial fibrosis, those which can predict the recurrence risk after AF ablation.

Detailed Description

Patients prone to AF ablation and do not object to participate at PROFIB-AF study will be offered, in parallel of their conventional care, blood samples the day of AF ablation by femoral and sinusal punctures and 12 months after ablation by venipuncture for the biomarkers analysis.

As part of their traditional care, these patients will benefit several exams beforeAF ablation (MRI, clinical examination ECG, echocardiography, routine biological analyzes), and four follow-up visits after AF ablation (at 3, 6, 9 and 12 months post-ablation) to evaluate AF recurrence, occurrence of MACE and heart failure signs.

Conditions

Women and Men Over 18 Years Old; AF Ablation (ECS recommendation2020&ACS2014) Either for Paroxysmal AF Unresponsive to Anti-arrhythmic Treatment Either for Persisting Symptomatic AF; Able to Give His Non Opposition to Participate to the Study

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult patient, male or female, eligible for an AF ablation procedure according to the recommendations (European Society of Cardiology 2020 and American Society of Cardiology 2014), either for symptomatic paroxysmal AF refractory to anti-arrhythmic treatments (or in first intention according to patient preference), or for symptomatic persistent AF.
• Able to give their non-opposition to participate in the research.
• Affiliation to a social security regime.

Exclusion Criteria

• Any pro-fibrotic phenomenon that may interfere with the interpretation of the results, i.e. severe valvular heart disease, amyloid heart disease, dilated cardiomyopathy of non-rhythmic origin, hypertrophic cardiomyopathy, severe ischaemic heart disease (late revascularisation, LV dysfunction, disturbed kinetics), COPD > stage 2, pulmonary fibrosis, renal failure > stage 3A, hepatic cirrhosis, hepatocellular failure, recent invasive surgery < 3 months
• Life expectancy less than 1 year
• Pregnant or breastfeeding women
• Patients of legal age under protective supervision (guardianship, trusteeship)
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupama foundation

UNKNOWN

Sponsor Role: collaborator

Biochemistry Lab University Hospital Clermont-Ferrand

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grégoire Massoulié

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

Other Identifiers

2021-A02091-40

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2021 MASSOULIE

Identifier Type: -

Identifier Source: org_study_id