Stepwise strategy to treat atrial fibrillation–related left atrial remodeling

Effects on Sinus Rhythm Maintenance and Atrial Remodeling After Cardioversion of Persistent Atrial Fibrillation: a Prospective, Multi-center, Cohort Study-stepwise Strategy for Treatment of Atrialfibrillation Substrate Study

Researchers will test whether sacubitril/valsartan can lower AF recurrence and improve left atrial structure and function in adults 18–80 with persistent atrial fibrillation and modest left atrial enlargement who undergo cardioversion and possible ablation.

Quick facts

• Study type: Observational
• Enrollment: 480 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing)
• Trial ID: NCT07129564 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective observational study in China enrolling adults 18–80 with persistent atrial fibrillation and left atrial anteroposterior diameter 40–50 mm who are willing to undergo cardioversion and planned amiodarone therapy. Participants will receive sacubitril/valsartan as part of routine care and be followed for atrial fibrillation recurrence, changes in cardiac structure and function, and maintenance of sinus rhythm after any ablation. Imaging with late gadolinium enhancement MRI and clinical follow-up will be used to quantify atrial fibrosis and correlate structural changes with outcomes. The study will analyze clinical and imaging factors associated with sustained sinus rhythm without randomized intervention.

Who should consider this trial

Good fit: Adults aged 18–80 with persistent atrial fibrillation, left atrial diameter 40–50 mm, willing to undergo pharmacological cardioversion with planned amiodarone and possible ablation, and able to give informed consent are ideal candidates.

Not a fit: Patients whose arrhythmia cannot be converted to sinus rhythm, those with eGFR <30 mL/min/1.73 m², pregnant or breastfeeding women, or those with significant hepatic disease or uncontrolled hyperthyroidism are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding sacubitril/valsartan could reduce atrial fibrillation recurrence and partly reverse left atrial fibrosis, improving symptoms and long-term heart function.

How similar studies have performed: Sacubitril/valsartan has proven benefits in heart failure and limited small studies suggest effects on atrial remodeling, but large-scale evidence that it reduces AF recurrence after ablation is currently limited, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

Aged 18-80 years, with persistent atrial fibrillation complicated by left atrial enlargement (left atrial anteroposterior diameter 40-50mm); Having the willingness to undergo atrial fibrillation cardioversion and planned to receive amiodarone for pharmacological cardioversion; Having signed a written informed consent form for participation in the study; Not concurrently participating in any other interventional studies.

Exclusion Criteria:

Females who are pregnant, lactating, or planning to have children within the next 2 years; Patients whose arrhythmia fails to convert to sinus rhythm with medication and who refuse electrical cardioversion; Patients whose arrhythmia cannot be converted to sinus rhythm with either medication or electrical cardioversion; Glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² (calculated by the CKD-EPI formula); Patients with biliary cirrhosis or cholestasis; Hyperthyroidism; A history of bradycardia (heart rate \< 50 beats/min) or atrioventricular block of second degree or higher; Sick sinus syndrome; Known allergy to iodine, amiodarone, or any of its excipients; Concomitant use of other drugs that prolong the QT interval, or a history of torsades de pointes; Contraindications to atrial fibrillation cardioversion, such as cardiac thrombosis or contraindications to anticoagulation;

A history or current presence of the following diseases or conditions:

1. Moderate to severe rheumatic heart disease, valvular heart disease; a history of atrial-related surgery, including valve replacement, radiofrequency ablation for atrial fibrillation/atrial tachycardia/atrial flutter, atrial septal defect occlusion, or complex congenital heart disease surgery;
2. A history of myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months;
3. NYHA Class III-IV congestive heart failure or EF \< 40%;
4. Patients judged by the investigator to have poor compliance, inability to complete the study as required, or an expected lifespan of less than 1 year.

Where this trial is running

Chongqing

• the second affiliated hospital of CQMU — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Yuehui Yin

Conditions Atrial Fibrillation