NCT05528419CompletedPhase 4
Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
Study name: Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation. Medicine: sacubitril/valsartan (100mg) and valsartan (80mg). Rationale: The latest guidelines represent an intensified management approach to reduce or prevent morbidity associated with atrial fibrillation. They provide stronger and more specific recommendations for catheter ablation (CA) use. However, not all patients maintain sinus rhythm after CA and both early and late relapses of AF can occur in many patients. Objective: To evaluate the efficacy and safety of sacubitril/valsartan in preventing atrial fibrillation recurrences after ablation in elderly hypertensive patients with atrial fibrillation. Study design: This is a 12-month prospective, randomized, active-controlled, open-label, multi-center study, with two treatment groups: sacubitril/valsartan (100mg tablet) and valsartan (80mg tablet). Study population: Men or women aged between 55 and 80 years will be screened for hypertension. Eligible patients should be untreated and treated atrial fibrillation patients with clinic systolic/diastolic blood pressure ≥130/80 mmHg, who are going to receive catheter ablation procedure. Patients should have abilities to understand the study requirements and provide informed consent. Randomization and treatment: After screening period by centers, eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (100mg tablet) or valsartan (80mg tablet). Follow-up: After meeting the inclusion criteria, there will be 1-week screening period. Clinic blood pressure, ambulatory blood pressure, echocardiography, concomitant medication records and adverse event records will be collected at randomization period. Then patients will be randomly assigned into sacubitril/valsartan group and valsartan group. The treatment will be observed for 12 months. There will be 4 visiting points in the treatment period, which will be the 1st month, 3rd month, 6th month and 12th month. Sample size: A total of 320 patients should be enrolled in total. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital, recruitment will start. Patients enrollment and follow-up are expected to be performed from October 2022 to June 2026.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 320 (actual)
- First submitted
- 2 Sept 2022
- Start date
- 6 Feb 2023
- Primary completion date
- 22 Jan 2026
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Atrial fibrillation, High blood pressure
- NCT number
- NCT05528419
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 320
- From 6 Feb 2023 to the primary completion date, 22 Jan 2026
- 1 site in 1 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
- Implanted pacemaker or defibrillator, myocardial infarction or percutaneous coronary intervention of ≤ 6 months before ablation;
- Patients who are receiving other study drugs or study medical devices;
Other illness
- Secondary hypertension;
- Coronary heart disease, valvular heart disease, hypertrophic cardiomyopathy, pulmonary heart disease, hyperthyroidism or hypothyroidism;
Lab values
- New York Heart Association functional class IV, or left ventricular ejection fraction of \<30%;
- Serum potassium \>5.5 mmol/L;
Other
- Clinic SBP/DBP≥180/110 mmHg, or 24-h ambulatory mean SBP/DBP\<120/70 mmHg;
- Presence of LA thrombus on transesophageal echocardiography;
- Severe hepatic or severe renal dysfunction estimated glomerular filtration rate of \< 30 mL/min\*per1.73 m2;
- Pregnant or lactating women;
- Other circumstances that patients are not appropriate for the study upon the investigator's judgment;
- Unwilling or unable to provide informed consent.
Who the study is looking for
- Aged 55-80;
- Persistent ot paroxysmal atrial fibrillation patients who are going to receive catheter ablation surgery;
- Clinic systolic blood pressure (SBP) ≥ 130 or diastolic blood pressure (DBP) ≥ 80 mmHg) in untreated and treated patients；
- Ability to understand the study requirements and provide informed consent.
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.