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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528419
• Other study ID #: SUPERIOR
• Status: Recruiting
• Phase: Phase 4
• Start date: February 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 65 and 79 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 300 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 December 2024.

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 65 and 79 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 300 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 December 2024.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Aged 65-79;

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, diabetes mellitus, 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Recurrent
• Hypertension
• Recurrence

Intervention

Drug:
• Sacubitril-valsartan
sacubitril valsartan 100mg initiated, and titrated to 200mg according to mean clinic blood pressure at 1-month follow-up
• Valsartan
valsartan 80mg initiated, and titrated to 160mg according to mean clinic blood pressure at 1-month follow-up

Locations

Country	Name	City	State
China	Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in mean office and ambulatory blood pressure after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Change in NT-proBNP after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Change in left atrial GLS from echocardiograph after 12-month treatment from baseline in each group		Baseline and 12 months
Secondary	Change in mean office blood pressure after 3-month treatment from baseline in each group		Baseline and 3 months
Secondary	Change in NT-proBNP after 3-month treatment from baseline in each group		Baseline and 3 months
Secondary	Change in left atrial GLS from echocardiograph after 3-month treatment from baseline in each group		Baseline and 3 months