Clinical trial NCT05179902: Predictive Properties of Myocardial Fibrosis Biomarkers on the Outcome of Atrial Fibrillation Ablation
Official title: Predictive Properties of Myocardial Fibrosis Biomarkers on the Outcome of Atrial Fibrillation Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Keywords: Atrial fibrillation (AF)
Myocardial fibrosis
AF ablation
AF recurrence
Biological collection
AF and myocardial fibrosis biological markers
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Groupama foundation
name: Biochemistry Lab University Hospital Clermont-Ferrand
First posted: 2022-01-06
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patient 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.

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.

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

Primary outcomes:
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at pre-ablation (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at 3 months (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at 6 months (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at 12 months (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at pre-ablation (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at 3 months (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at 6 months (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: Any AF episode >30 seconds at 12 months (yes or no)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: PIIINP at pre-ablation (in ng/mL
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: PIIINP at 12 months (in ng/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: ICTP at pre-ablation (in ng/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: ICTP at 12 months (in ng/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: PICP at pre-ablation (in ng/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: PICP at 12 months (in ng/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: sRAGE at pre-ablation (in pg/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: sRAGE at 12 months (in pg/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: AGE at pre-ablation (in ng/mL)
measure: Occurrence of an atrial fibrillation recurrence
timeFrame: AGE at 12 months (in ng/mL)
Secondary outcomes:
measure: Rate of fibrosis of the left atrium
timeFrame: Degree of left atrial fibrosis on MRI at the inclusion (pre-ablation; in %)
measure: Rate of fibrosis of the left atrium
timeFrame: Endocardial left atria low voltage area (<0.5mV) in sinus rhythm (in %)
measure: Dominant frequency of AF
timeFrame: F wave frequency at the inclusion (pre-ablation; in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 3 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 6 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 12 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at the inclusion (pre-ablation; in mv)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at 3 months (in mv)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at 6 months (in mv)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at 12 months (in mv)
measure: Dominant frequency of AF
timeFrame: AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 3 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 6 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 12 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF duration at the inclusion (pre-ablation, in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 3 months (in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 6 months (in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 12 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at the inclusion (pre-ablation; in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 3 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 6 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 9 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 12 months (in ms)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at the inclusion (pre-ablation; in mV)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at 3 months (in mV)
measure: Dominant frequency of AF
timeFrame: F wave frequency at 6 months (in mV)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at 9 months (in mV)
measure: Dominant frequency of AF
timeFrame: F wave amplitude at 12 months (in mV)
measure: Dominant frequency of AF
timeFrame: AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 3 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 6 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 9 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF characteristics at 12 months (paroxysmal, persistent)
measure: Dominant frequency of AF
timeFrame: AF duration at the inclusion (pre-ablation; in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 3 months (in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 6 months (in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 9 months (in ms)
measure: Dominant frequency of AF
timeFrame: AF duration at 12 months (in ms)
measure: Dominant frequency of AF
timeFrame: Left atria volume at pre-ablation (mL)
measure: Dominant frequency of AF
timeFrame: Left atria volume at 12 months (mL)
measure: Dominant frequency of AF
timeFrame: Indexed left atria volume at pre-ablation (mL)
measure: Dominant frequency of AF
timeFrame: Indexed left atria volume at 12 months (mL)
measure: Dominant frequency of AF
timeFrame: LVEF at the inclusion (pre-ablation; %)
measure: Dominant frequency of AF
timeFrame: LVEF at 12 months (%)
measure: Dominant frequency of AF
timeFrame: Hemoglobin at pre-ablation (in g/dL)
measure: Dominant frequency of AF
timeFrame: Hemoglobin at 12 months (in g/dL)
measure: Dominant frequency of AF
timeFrame: HbA1c at pre-ablation (in %)
measure: Dominant frequency of AF
timeFrame: HbA1c at 12 months (in %)
measure: Dominant frequency of AF
timeFrame: Kalemia at pre-ablation (in mmol/L)
measure: Dominant frequency of AF
timeFrame: Kalemia at 12 months (in mmol/L)
measure: Dominant frequency of AF
timeFrame: Natremia at pre-ablation (in mmol/L)
measure: Dominant frequency of AF
timeFrame: Natremia at 12 months (in mmol/L)
measure: Dominant frequency of AF
timeFrame: Glycemia at pre-ablation (in mmol/L)
measure: Dominant frequency of AF
timeFrame: Glycemia at 12 months (in mmol/L)
measure: Dominant frequency of AF
timeFrame: Total bilirubin at pre-ablation (in µmol/L)
measure: Dominant frequency of AF
timeFrame: Total bilirubin at 12 months (in µmol/L)
measure: Dominant frequency of AF
timeFrame: ASAT at pre-ablation (in U/L)
measure: Dominant frequency of AF
timeFrame: ASAT at 12 months (in U/L)
measure: Dominant frequency of AF
timeFrame: ALAT at pre-ablation (in U/L)
measure: Dominant frequency of AF
timeFrame: ALAT at 12 months (in U/L)
measure: Dominant frequency of AF
timeFrame: GGT at pre-ablation (in U/L)
measure: Dominant frequency of AF
timeFrame: GGT at 12 months (in U/L)
measure: Dominant frequency of AF
timeFrame: PAL at pre-ablation (in U/L)
measure: Dominant frequency of AF
timeFrame: PAL at 12 months (in U/L)
measure: Dominant frequency of AF
timeFrame: LDH at pre-ablation (in U/L)
measure: Dominant frequency of AF
timeFrame: LDH at 12 months (in U/L)
measure: Dominant frequency of AF
timeFrame: Creatinine level at pre-ablation (in µmol/L)
measure: Dominant frequency of AF
timeFrame: Creatinine level at 12 months (in µmol/L)
measure: Dominant frequency of AF
timeFrame: Clearance CKD-EPI at pre-ablation (ml/min/1.73m²)
measure: Dominant frequency of AF
timeFrame: Clearance CKD-EPI at 12 months (ml/min/1.73m²)
measure: Dominant frequency of AF
timeFrame: Urea at pre-ablation (mmol/L)
measure: Dominant frequency of AF
timeFrame: Urea at 12 months (mmol/L)
measure: Dominant frequency of AF
timeFrame: Protidemia at pre-ablation (g/L)
measure: Dominant frequency of AF
timeFrame: Protidemia at 12 months (g/L)
measure: Dominant frequency of AF
timeFrame: NTproBNP at pre-ablation (ng/L)
measure: Dominant frequency of AF
timeFrame: NTproBNP at 12 months (ng/L)
measure: Dominant frequency of AF
timeFrame: TSH at pre-ablation (mUI/L)
measure: Dominant frequency of AF
timeFrame: TSH at 12 months (mUI/L)
measure: Dominant frequency of AF
timeFrame: T3 at pre-ablation (pmol/L)
measure: Dominant frequency of AF
timeFrame: T3 at 12 months (pmol/L)
measure: Dominant frequency of AF
timeFrame: T4 at pre-ablation (pmol/L)
measure: Dominant frequency of AF
timeFrame: T4 at 12 months (pmol/L)
measure: Dominant frequency of AF
timeFrame: Galectin-3 at pre-ablation (in ng/mL)
measure: Dominant frequency of AF
timeFrame: Galectin-3 at 12 months (in ng/mL)
measure: Dominant frequency of AF
timeFrame: sST2 at pre-ablation (in ng/mL)
measure: Dominant frequency of AF
timeFrame: sST2 at 12 months (in ng/mL)
measure: Dominant frequency of AF
timeFrame: miRNAs at pre-ablation (fold change)
measure: Dominant frequency of AF
timeFrame: miRNAs at 12 months (fold change)
measure: Dominant frequency of AF
timeFrame: Diabete at pre-ablation (yes, type I, type II or no)
measure: Dominant frequency of AF
timeFrame: Body weight at pre-ablation (in kg)
measure: Dominant frequency of AF
timeFrame: Body weight at 3 months (in kg)
measure: Dominant frequency of AF
timeFrame: Body weight at 6 months (in kg)
measure: Dominant frequency of AF
timeFrame: Body weight at 12 months (in kg)
measure: Dominant frequency of AF
timeFrame: Body height at pre-ablation (in cm)
measure: Dominant frequency of AF
timeFrame: Body height at 3 months (in cm)
measure: Dominant frequency of AF
timeFrame: Body height at 6 months (in cm)
measure: Dominant frequency of AF
timeFrame: Body height at 12 months (in cm)
measure: Dominant frequency of AF
timeFrame: Systolic blood pressure at pre-ablation (in mmHg)
measure: Dominant frequency of AF
timeFrame: Systolic blood pressure at 3 months (in mmHg)
measure: Dominant frequency of AF
timeFrame: Systolic blood pressure at 6 months (in mmHg)
measure: Dominant frequency of AF
timeFrame: Systolic blood pressure at 12 months (in mmHg)
measure: Dominant frequency of AF
timeFrame: Diastolic blood pressure at pre-ablation (in mmHg)
measure: Dominant frequency of AF
timeFrame: Diastolic blood pressure at 3 months (in mmHg)
measure: Dominant frequency of AF
timeFrame: Diastolic blood pressure at 6 months (in mmHg)
measure: Dominant frequency of AF
timeFrame: Diastolic blood pressure at 12 months (in mmHg)
measure: Dominant frequency of AF
timeFrame: Cardiac frequency pressure at pre-ablation (in bpm)
measure: Dominant frequency of AF
timeFrame: Cardiac frequency pressure at 3 months (in bpm)
measure: Dominant frequency of AF
timeFrame: Cardiac frequency pressure at 6 months (in bpm)
measure: Dominant frequency of AF
timeFrame: Cardiac frequency pressure at 12 months (in bpm)
measure: Dominant frequency of AF
timeFrame: NYHA score at pre-ablation (I, II, III or IV)
measure: Dominant frequency of AF
timeFrame: NYHA score at 3 months (I, II, III or IV)
measure: Dominant frequency of AF
timeFrame: NYHA score at 6 months (I, II, III or IV)
measure: Dominant frequency of AF
timeFrame: NYHA score at 12 months (I, II, III or IV)
measure: Dominant frequency of AF
timeFrame: Congestive signs at pre-ablation (yes, left, right, global; or not)
measure: Dominant frequency of AF
timeFrame: Congestive signs at at 3 months (yes, left, right, global; or not)
measure: Dominant frequency of AF
timeFrame: Congestive signs at 6 months (yes, left, right, global; or not)
measure: Dominant frequency of AF
timeFrame: Congestive signs at 12 months (yes, left, right, global; or not)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Grégoire Massoulié
role: PRINCIPAL_INVESTIGATOR
References: