NCT07910058Not yet recruitingPhase 4
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
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 472 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Ruijin Hospital
- Diseases
- Atrial fibrillation, High blood pressure
- NCT number
- NCT07910058
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 472
- From 31 Oct 2026 to the primary completion date, 31 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major cardiovascular events or cerebrovascular diseases within 3 months prior to ablation..
- Acute/severe systemic infection within 1 month prior to ablation, or left atrial/appendage thrombus.
Other illness
- Diagnosed secondary hypertension or hypertension (mean office blood pressure ≥140/90 mmHg or taking ≥2 antihypertensives).
- History of symptomatic hypotension, or baseline SBP \<100 mmHg.
- Valvular atrial fibrillation (moderate-to-severe mitral stenosis or regurgitation, or mechanical heart valves), cardiomyopathy, cor pulmonale, or coexisting hyperthyroidism or hypothyroidism.
- Hepatic or renal impairment, defined as alanine aminotransferase or aspartate aminotransferase levels \>2 times the upper limit of normal, or estimated glomerular filtration rate \<30 mL/min/1.73 m2.
- Pregnant or breastfeeding women, psychiatric disorders, or participation in other clinical trials.
Lab values
- New York Heart Association (NYHA) functional class IV heart failure, or LVEF \< 40%.
- Serum potassium \>5.5 mmol/L.
Other
- Left atrial anteroposterior diameter \>55 mm.
Who the study is looking for
- Written informed consent obtained prior to any study procedure.
- Age between 18 and 79 years, male or female.
- Diagnosis of persistent non-valvular atrial fibrillation scheduled for first catheter ablation..
- Baseline mean office blood pressure in the non-hypertensive category: Non-elevated BP (100/55 to 120/70 mmHg without antihypertensives) OR Elevated BP (SBP 120-139 mmHg or DBP 70-89 mmHg).
- Left ventricular ejection fraction (LVEF) ≥ 40% by echocardiography.
- Willingness and ability to comply with scheduled visits and study procedures.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.