A multicenter, randomized, double-blind, placebo-controlled clinical study for Shensong Yangxin Capsule on prognosis in patients with atrial fibrillation undergoing radiofrequency ablation

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026912

Enrollment

Unknown

Registered

2019-10-26

Start date

2019-10-28

Completion date

Unknown

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

experimental group:routine treatment + Shensong Yangxin Capsule 4 capsules per time, 3 times per day, oral administration

control group:routine treatment + Shensong Yangxin Capsule placebo 4 pills per time, 3 times per day, oral administration

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18-75 years old; (2) Diagnosis of persistent atrial fibrillation; (3) History of atrial fibrillation < 5 years ; (4) Radiofrequency catheter ablation was performed for the first time. (5) Voluntary participation in this study and informed consent has been signed.

Exclusion criteria

Exclusion criteria: (1) Valvular atrial fibrillation; (2) NYHA cardiac function grade IV or LVEF 50 mm; (3) Moderate to severe left ventricular hypertrophy (wall thickness > 1.5 cm); (4) Patients with acute coronary syndrome or patients requiring stent implantation; (5) Patients with cardiac surgery in the past 6 months; (6) History of atrial fibrillation >= 5 years (7) Hyperthyroidism; (8) Patients with atrial fibrillation with cardiomyopathy; (9) Slow arrhythmia requiring pacemaker installation; (10) Known hemorrhagic constitution and presence of left atrial/left atrial appendage thrombosis or severe hemostasis and coagulation dysfunction; (11) Severe liver and kidney insufficiency (ALT > 3ULN or eGFR < 50ml/min/1.73m2); (12) Patients with neuropsychiatric disorders; (13) Allergic to the constituents of this study; (14) Pregnant or lactating women; (15) Patients who are participating in other clinical studies; (16) Researchers believe that it is not suitable for patients to participate in this study.

Design outcomes

Primary

Measure	Time frame
atrial fibrillation;	—

Secondary

Measure	Time frame
AF load;first atrial flutter/atrial fibrillation;cardioversion;transthoracic echocardiographic;stroke and thromboembolism;The score of SF-36;	—

Countries

China

Contacts

Public ContactHuang He

People's Hospital of Wuhan University

huanghe1977@whu.edu.cn+86 15994207265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026