Effect of Sacubitril/Valsartan on the recurrence of atrial fibrillation after catheter ablation

JRCT ID: jRCT1061230045

Registered date:08/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 08/08/2023
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Sacubitril/Valsartan(SV) or Valsartan(V) is administered in the day before undergoing catheter ablation. The initial dose of SV is 100mg, V is 40mg once a day. The SV and V dose are titrated to 200mg, 80mg once a day respectively if the syst
olic pressure is > 120mmHg and no symptoms caused by hypotension. We try to reach to the target dose as possible, and it would be considered that other antihypertensive drug is gradually reduced and stopped until reaching the dose. Patients are a
dministrated SV or V account to the assined groupfor 12 months and then stopped the administration.

Outcome(s)

• Primary Outcome: Reccurence rate of atrial fibrillation 12 months after catheter ablation

Secondary Outcome

Supraventricular arrhythmias lasting >24 hours
Left atrial diameter and left atrial volume, peak atrial longitudinal strain

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Patients who are aged 20 years and older, and younger than 80 years.
2. Patients who are scheduled to undergo catheter ablation for persistent atrial fibrillation at the first time, and with hypertension.
3. Patients who give written informed consents before treatment.

Exclude criteria

1. NYHA class4
2. Hyperthyroidism or hypothyroidism
3. Moderate or severe mitral disease
4. Severe renal dysfunction(eGFR<30ml/min/1.73m2)
5. The presence of a prosthetic heart valve
6. Presence of thrombus in left atrial appendage on transesophageal echocardiography
7. History of hypersensitivity to Sacubitril/Valsartan or Valsartan
8. History of angioedema due to angiotensin 2 receptor antagonist or angiotensin convertinf enzyme inhibitor , Hereditary/Aquired Angioedema, or idiopathic angioedema
9. Administration of aliskiren fumarate to diabetes mellitus
10. Severe hepatic dysfunction(Child Pugh C)
11. Pregnant, unwilling to practice contraception during the study, or lactation female
12. Patients who are participating, or intend to participate in other clinical trials during the study
13. Patients who obstruct, bind or confuse the specific assessment about protcol in the study
14. Principal Investigator involving in the study, or employees of the participating medical center, or their family

Related Information

• Primary Sponsor: Nakano Yukiko