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

Atrial Fibrillation Clinical Trial

— REBECCA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02958839
• Other study ID #: L03-ZZK-FGF23
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 4, 2016
• Last updated: November 4, 2016
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• Catheter ablation
Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Meng L, Yang Y, Zhang Z, Li G, Liu T. Predictive value of circulating fibroblast growth factor-23 on atrial fibrillation: A meta-analysis. Int J Cardiol. 2016 May 1;210:68-71. doi: 10.1016/j.ijcard.2016.02.100. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the recurrence of atrial fibrillation	The 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	after 3 months from the procedure of catheter ablation	No
Secondary	Plasma fibroblast growth factor 23 levels	Fibroblast Growth Factor 23 plays an important role in cardiac remodeling and is considered to be independently associated with the occurrence of atrial fibrillation	after 3 months from the procedure of catheter ablation	No
Secondary	CHA2DS2-VASc score	CHA2DS2-VASc score is used to measure the risk of thrombotic event in patient with atrial fibrillation	after 3 months from the procedure of catheter ablation	No
Secondary	Cardiac CT evaluation	To evaluate the degree of fibrosis of the left and right atrium and pulmonary veins	after 3 months from the procedure of catheter ablation	No