Atrial FibrillationREBECCANCT02958839
Relationship Between Fibroblast Growth Factor 23 and Recurrence of Atrial Fibrillation After Catheter Ablation
An observational study of Atrial Fibrillation, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2017
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. Atrial fibrillation is diagnosed according to guidelines; Patients with structural heart disease; renal or hepatic impairment; neoplastic disorders; atrial fibrillation precipitated by other diseases such as thyrotoxicosis; or diabetes will be excluded.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100019
About this study
Official title: The Relationship Between Fibroblast Growth Factor 23 and the Recurrence of Atrial Fibrillation After Catheter Ablation: a Nested Case-Control Study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation
- Keywords
- Atrial fibrillation, Fibroblast Growth factor 23
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| Recurrence Group | In the case control trial, patients who have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group Receives: Procedure: Catheter ablation | |
| Non-recurrence Group | In the case control trial, patients who do not have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 3 months from the procedure of catheter ablation
Secondary outcomes (3)
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
Measured: after 3 months from the procedure of catheter ablation
CHA2DS2-VASc score
CHA2DS2-VASc score is used to measure the risk of thrombotic event in patient with atrial fibrillation
Measured: after 3 months from the procedure of catheter ablation
Cardiac CT evaluation
To evaluate the degree of fibrosis of the left and right atrium and pulmonary veins
Measured: after 3 months from the procedure of catheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Peking University Third HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongkai Zhao, Peking University Third Hospital
- Investigators
- Lei Li, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958839
- Sponsor's protocol ID
- L03-ZZK-FGF23
- Acronym
- REBECCA
- Status last verified
- Nov 2016
- First submitted
- 4 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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. Epub 2016 Feb 18. No abstract available.
PubMed 26942328
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fibroblast Growth Factor 23 and the Recurrence of Atrial Fibrillation After Catheter Ablation: a Nested Case-Control Study
- ClinicalTrials.gov ID
- NCT02958839
- Acronym / sponsor ID
- REBECCA / L03-ZZK-FGF23
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Fibroblast Growth factor 23
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 8 Nov 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrence Group | – | Procedure: Catheter ablationIn the case control trial, patients who have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group |
| Non-recurrence Group | – | Procedure: Catheter ablationIn the case control trial, patients who do not have any episode of atrial fibrillation/atrial flutter/atrial tachycardia after a blanking period of 3 months from the catheter ablation procedure will be assign to the recurrence group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. Atrial fibrillation is diagnosed according to guidelines; Patients with structural heart disease; renal or hepatic impairment; neoplastic disorders; atrial fibrillation precipitated by other diseases such as thyrotoxicosis; or diabetes will be excluded.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationPatients with persistent or paroxysmal atrial fibrillation will go through catheter ablation | Procedure or surgery | Non-recurrence Group, Recurrence Group |
Primary outcome
Incidence of the recurrence of atrial fibrillation
Time frame: after 3 months from the procedure of catheter ablation
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
3 secondary outcomes
Plasma fibroblast growth factor 23 levels
Time frame: after 3 months from the procedure of catheter ablation
CHA2DS2-VASc score
Time frame: after 3 months from the procedure of catheter ablation
Cardiac CT evaluation
Time frame: after 3 months from the procedure of catheter ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Background: PubMed 26942328Meng 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. Epub 2016 Feb 18. No abstract available.
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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.
Lei Li, MD study director
Peking University Third Hospital
1 site 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 Peking University Third Hospital at 1 site in China.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
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?
Incidence of the recurrence of atrial fibrillation (time frame: after 3 months from the procedure of catheter ablation). 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 NCT02958839, which also lists 1 linked publication.
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 8 Nov 2016.