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Relationship Between Fibroblast Growth Factor 23 and Recurrence of Atrial Fibrillation After Catheter Ablation

The Relationship Between Fibroblast Growth Factor 23 and the Recurrence of Atrial Fibrillation After Catheter Ablation: a Nested Case-Control Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02958839
Acronym
REBECCA
Enrollment
200
Registered
2016-11-08
Start date
2016-11-30
Completion date
2017-11-30
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Fibroblast Growth factor 23

Brief summary

To investigate whether fibroblast growth factor 23 can be used to predict recurrence after catheter ablation for atrial fibrillation and to provide an objective basis for the clinical selection of the optimal patients for catheter ablation.

Detailed description

Atrial fibrillation, which can result in stroke and thromboembolism in an approximately 5-fold increased risk, has been a great burden to health care system with the aging of population. Catheter ablation is the most promising treatment of atrial fibrillation. However, the recurrence rates of AF after catheter ablation are high, ranging from 20%-60%. Therefore, non-invasive predictors for AF recurrence after catheter ablation is necessary to select the optimal patients for this procedure. Fibroblast growth factor-23 (FGF-23) is a bone-derived hormone that plays a central role in phosphate homeostasis. Recent study showed that fibroblast growth factor 23 plays an important role in cardiac remodeling and is considered to be independently associated with the occurrence of atrial fibrillation. In this study, we are going to observe the relationship between the serum FGF-23 and the arrythmia recurrence after catheter ablation of AF. This research is going to recruit 200 consecutive patients with a history of atrial fibrillation for 180-360 days who intend to undergo catheter ablation. The day before catheter ablation, serum FGF-23 level will be detected. Echocardiogram and left atrial CT scan will also be performed on the day before catheter ablation. All patients will be routinely follow up in the outpatient department by cardiologists every month for 1 year. If patients complain about palpitations, fatigue, or other symptoms related to arrhythmia, Holter monitoring will be performed. Patients will also be advised to see their doctor anytime they have these symptoms and to undergo a 12-lead ECG examination or 24-hour Holter monitoring. In asymptomatic patients, 24-hour Holter monitoring or 7-day cardiac event recording will be performed every three months after the procedure. The endpoint for follow-up is the recurrence of atrial fibrillation, which is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation. Those who develop recurrence of AF during follow up will be assigned to recurrence group, and those who do not develop recurrence of AF during follow up will be assigned to non-recurrence group. Comparison of the serum FGF-23 level between the two groups will be carried out in order to investigate the relationship between serum FGF-23 level and the recurrence of AF.

Interventions

PROCEDURECatheter ablation

Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Have a history of atrial fibrillation for 180 to 360 days * Provide written informed consent, having understood the benefits and risks of participation in the trial

Exclusion criteria

* Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation) * Atrial Fibrillation precipitated by other diseases (such as thyrotoxicosis) * Severe dysfunction of liver or kidney * Diabetes * Malignant tumor * Inability or refusal to provide written informed consent for the study

Design outcomes

Primary

MeasureTime frameDescription
Incidence of the recurrence of atrial fibrillationafter 3 months from the procedure of catheter ablationThe recurrence of atrial fibrillation is considered to be any episode of AF/AFL/AT after a blank period of 3 months after the procedure of catheter ablation

Secondary

MeasureTime frameDescription
Plasma fibroblast growth factor 23 levelsafter 3 months from the procedure of catheter ablationFibroblast Growth Factor 23 plays an important role in cardiac remodeling and is considered to be independently associated with the occurrence of atrial fibrillation
CHA2DS2-VASc scoreafter 3 months from the procedure of catheter ablationCHA2DS2-VASc score is used to measure the risk of thrombotic event in patient with atrial fibrillation
Cardiac CT evaluationafter 3 months from the procedure of catheter ablationTo evaluate the degree of fibrosis of the left and right atrium and pulmonary veins

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026