Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation

Shanghai Jiao Tong University School of Medicine

Status and phase: Active, not recruiting; Phase 4

Conditions: Hypertension; Atrial Fibrillation Recurrent

Treatments: Drug: Valsartan; Drug: Sacubitril-valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT05528419

SUPERIOR

Details and patient eligibility

About

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.

Full description

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.

Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Enrollment: 320 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 55-80;
2. Persistent ot paroxysmal atrial fibrillation patients who are going to receive catheter ablation surgery;
3. Clinic systolic blood pressure (SBP) ≥ 130 or diastolic blood pressure (DBP) ≥ 80 mmHg) in untreated and treated patients；
4. Ability to understand the study requirements and provide informed consent.

Exclusion criteria

1. Secondary hypertension;
2. Clinic SBP/DBP≥180/110 mmHg, or 24-h ambulatory mean SBP/DBP<120/70 mmHg;
3. Coronary heart disease, valvular heart disease, hypertrophic cardiomyopathy, pulmonary heart disease, hyperthyroidism or hypothyroidism;
4. New York Heart Association functional class IV, or left ventricular ejection fraction of <30%;
5. Implanted pacemaker or defibrillator, myocardial infarction or percutaneous coronary intervention of ≤ 6 months before ablation;
6. Presence of LA thrombus on transesophageal echocardiography;
7. Severe hepatic or severe renal dysfunction estimated glomerular filtration rate of < 30 mL/min*per1.73 m2;
8. Serum potassium >5.5 mmol/L;
9. Pregnant or lactating women;
10. Other circumstances that patients are not appropriate for the study upon the investigator's judgment;
11. Patients who are receiving other study drugs or study medical devices;
12. Unwilling or unable to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Sacubitril valsartan

Experimental group

Treatment:

Drug: Sacubitril-valsartan

Valsartan

Active Comparator group

Treatment:

Drug: Valsartan