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

NCT05528419 | Completed Phase 4 DMC

• 1 other identifier: SUPERIOR
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation Recurrent; Hypertension

Keywords

elderly; ablation; blood pressure

Outcome Measures

Primary Outcomes (1)

• Any documented atrial arrhythmia (AF, atrial flutter, or atrial tachycardia) episode lasting for at least 30 s after a 3-month blanking period

  3-12 months

Secondary Outcomes (7)

• Any documented atrial arrhythmia (AF, atrial flutter, or atrial tachycardia) episode lasting for at least 30 s within the 3-month blanking period.

  0-3 months

• Change in mean office and ambulatory blood pressure after 12-month treatment from baseline in each group

  Baseline and 12 months

• Change in NT-proBNP after 12-month treatment from baseline in each group

  Baseline and 12 months

• Change in left atrial GLS from echocardiograph after 12-month treatment from baseline in each group

  Baseline and 12 months

• Change in mean office blood pressure after 3-month treatment from baseline in each group

  Baseline and 3 months

Study Arms (2)

Sacubitril valsartan

EXPERIMENTAL

Drug: Sacubitril-valsartan

Valsartan

ACTIVE COMPARATOR

Drug: Valsartan

Interventions

Valsartan DRUG

valsartan 80mg initiated, and titrated to 160mg according to mean clinic blood pressure at 1-month follow-up

Valsartan

Sacubitril-valsartan DRUG

sacubitril valsartan 100mg initiated, and titrated to 200mg according to mean clinic blood pressure at 1-month follow-up

Sacubitril valsartan

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Model Details: After screening period, eligible patients will be randomly assigned into sacubitril/valsartan group (sacubitril/valsartan 80mg QD) or valsartan group (valsartan 80mg QD).

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 6, 2022
• Study Start: February 6, 2023
• Primary Completion: January 22, 2026
• Study Completion: February 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (1)