Atrial FibrillationNCT02776956
Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
A study testing atorvastatin group and non-atorvastatin group in people with Atrial Fibrillation, run by xieruiqin at 1 site in China.
Trial summary
A total of 120 patients with persistent atrial fibrillation (including continuous and long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial fibrillation will receive radiofrequency ablation. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- atorvastatin group and non-atorvastatin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Aug 2018
- Phase
- Interventional
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
- paroxysmal atrial fibrillation with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
- age is <80 years
Who cannot join
- left ventricular dysfunction
- LA >50 mm
- atrial thrombosis
- valvular heart disease
- hyperthyroidism
- patients who underwent prosthetic heart valve replacement
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- patients with previous history of atrial fibrillation ablation
- Hyperlipidemia
- pregnant women
- patients with existing liver and kidney disease
- malignant tumors
- hematological system diseases
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
A total of 120 patients with persistent atrial fibrillation (including continuous and long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial fibrillation will receive radiofrequency ablation. Patients in each group will be randomly allocated into the statin treatment group and non-statin treatment group (allocation ratio, 1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation. This study will clarify whether the application of statin drugs can improve postoperative left atrial function. This study will identify the time course and influence factors of left atrial recovery of atrial fibrillation after the operation to guide the time and the degree of anticoagulation and effectively prevent thromboembolic events. At the same time, biochemical indicators are detected to analyze which indicators are related to the postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis and the recovery of postoperative left atrial function. Furthermore, this study will investigate whether the application of statin drugs can improve postoperative left atrial function by affecting these indicators.
- Conditions
- Atrial Fibrillation
- Being tested
- atorvastatin group, non-atorvastatin group
- Keywords
- atrial fibrillation;left atrial function
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin groupDrug
Patients in atorvastatin group will orally receive 20 mg of atorvastatin per night (Pfizer) for three days before the operation and three months after the operation
non-atorvastatin groupDrug
Patients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation.
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin group | Experimental | atrial fibrillation in atorvastatin group will orally receive atorvastatin before and after operation. Receives: Drug: atorvastatin group |
| non-atorvastatin group | Other | atrial fibrillation in non-atorvastatin group will not receive atorvastatin before and after operation.. Receives: Drug: non-atorvastatin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial function of postoperative atrial fibrillation detected
Measured: 1-12 month
Secondary outcomes (1)
Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed
Measured: 1-3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- xieruiqin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xieruiqin, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776956
- Sponsor's protocol ID
- xierqdoctormd
- Status last verified
- Aug 2017
- First submitted
- 29 Apr 2016
- Last updated
- 24 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
- ClinicalTrials.gov ID
- NCT02776956
- Acronym / sponsor ID
- xierqdoctormd
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation;left atrial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- xieruiqinUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 19 May 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.
A total of 120 patients with persistent atrial fibrillation (including continuous and long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial fibrillation will receive radiofrequency ablation. Patients in each group will be randomly allocated into the statin treatment group and non-statin treatment group (allocation ratio, 1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation. This study will clarify whether the application of statin drugs can improve postoperative left atrial function. This study will identify the time course and influence factors of left atrial recovery of atrial fibrillation after the operation to guide the time and the degree of anticoagulation and effectively prevent thromboembolic events. At the same time, biochemical indicators are detected to analyze which indicators are related to the postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis and the recovery of postoperative left atrial function. Furthermore, this study will investigate whether the application of statin drugs can improve postoperative left atrial function by affecting these indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin group | Experimental | Drug: atorvastatin groupatrial fibrillation in atorvastatin group will orally receive atorvastatin before and after operation. |
| non-atorvastatin group | Other | Drug: non-atorvastatin groupatrial fibrillation in non-atorvastatin group will not receive atorvastatin before and after operation.. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
- paroxysmal atrial fibrillation with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
- age is <80 years
Key exclusion criteria (12 listed)
- left ventricular dysfunction
- LA >50 mm
- atrial thrombosis
- valvular heart disease
- hyperthyroidism
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 |
|---|---|---|
| atorvastatin groupPatients in atorvastatin group will orally receive 20 mg of atorvastatin per night (Pfizer) for three days before the operation and three months after the operation | Drug | atorvastatin group |
| non-atorvastatin groupPatients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation. | Drug | non-atorvastatin group |
Primary outcome
Left atrial function of postoperative atrial fibrillation detected
Time frame: 1-12 month
1 secondary outcome
Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed
Time frame: 1-3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin group and non-atorvastatin group in people with Atrial Fibrillation, run by xieruiqin 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 24 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left atrial function of postoperative atrial fibrillation detected (time frame: 1-12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2019.