Clinical trial NCT05528419: Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients with Atrial Fibrillation
Official title: Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients with Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation Recurrent
Hypertension
Keywords: elderly
ablation
blood pressure
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 320
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After screening period, eligible patients will be randomly assigned into sacubitril/valsartan group (sacubitril/valsartan 80mg QD) or valsartan group (valsartan 80mg QD).
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Any documented atrial arrhythmia (AF, atrial flutter, or atrial tachycardia) episode lasting for at least 30 s after a 3-month blanking period
timeFrame: 3-12 months
Secondary outcomes:
measure: Any documented atrial arrhythmia (AF, atrial flutter, or atrial tachycardia) episode lasting for at least 30 s within the 3-month blanking period.
timeFrame: 0-3 months
measure: Change in mean office and ambulatory blood pressure after 12-month treatment from baseline in each group
timeFrame: Baseline and 12 months
measure: Change in NT-proBNP after 12-month treatment from baseline in each group
timeFrame: Baseline and 12 months
measure: Change in left atrial GLS from echocardiograph after 12-month treatment from baseline in each group
timeFrame: Baseline and 12 months
measure: Change in mean office blood pressure after 3-month treatment from baseline in each group
timeFrame: Baseline and 3 months
measure: Change in NT-proBNP after 3-month treatment from baseline in each group
timeFrame: Baseline and 3 months
measure: Change in left atrial GLS from echocardiograph after 3-month treatment from baseline in each group
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: