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An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Sponsor: Ruijin Hospital
Summary
The goal of this clinical trial is to investigate the efficacy and safety of angiotensin receptor-neprilysin inhibitor (sacubitril/valsartan) in preventing recurrence of atrial fibrillation after catheter ablation in non-hypertension patients with persistent atrial fibrillation. This is a multicenter, randomized, open-label, parallel-group study in participants aged 18 to 79 years old who are hospitalized for planned catheter ablation of persistent atrial fibrillation and have a mean clinic blood pressure between 100/55 mmHg and 139/89 mmHg. The main questions it aims to answer are: 1. Does sacubitril/valsartan lower the proportion of late atrial tachyarrhythmia recurrence after catheter ablation in non-hypertensive patients with persistent AF? 2. How safe is sacubitril/valsartan in people with persistent atrial fibrillation who do not have hypertension? Researchers will compare sacubitril/valsartan with standard care (routine post-ablation care without ACE inhibitors, ARBs, or ARNI) to see if sacubitril/valsartan prevents AF recurrence after ablation. Participants will: 1. Be randomly assigned after ablation to receive sacubitril/valsartan or standard care. 2. Receive the assigned treatment and be followed for up to 12 months. 3. Attend clinic visits and tests to check for recurrent atrial arrhythmia and for safety. 4. Give blood samples before treatment and after 12 months of treatment for exploring potential molecular mechanisms.
Official title: Sacubitril/Valsartan for Preventing the Recurrence of Atrial Fibrillation After Catheter Ablation in Non-hypertensive Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
472
Start Date
2026-10-31
Completion Date
2029-06-30
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Sacubitril/Valsartan
50 mg twice daily (b.i.d.) for 12 months.
Standard Care
Routine post-ablation care without ACEI/ARB/ARNI drugs.