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A multicenter, prospective, real-world study on the ShenSongYangXin Capsules in the reduction of composite events of sudden cardiac death in patients with organic heart disease and ventricular arrhythmia

A multicenter, prospective, real-world study on the ShenSongYangXin Capsules in the reduction of composite events of sudden cardiac death in patients with organic heart disease and ventricular arrhythmia - ACCEPT

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084214
Enrollment
Unknown
Registered
2024-05-13
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Sudden cardiac death

Interventions

Study group (Conventional treatment for primary heart disease + Shensong Yangxin capsule):NA
Control group (Conventional treatment for primary heart disease):NA

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: The subjects included in this study are mainly patients with organic heart disease combined with ventricular rhythm. All patients receive treatment as prescribed by the guidelines for their respective primary diseases. The included patients should meet the following conditions: (1) Age =18 years; (2) Voluntarily participate in this study and sign an informed consent form; (3) According to the guidelines for the corresponding primary disease, they are clearly diagnosed with organic heart disease, including: coronary atherosclerotic heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, hypertension combined with cardiac hypertrophy, heart failure caused by other reasons (including heart failure with preserved ejection fraction, intermediate, reduced heart failure), heart valve disease without surgical or internal intervention indications; (4) Combined with ventricular arrhythmia: i. Survivors of cardiac arrest; ii. Have a record (ECG, Holter, bedside and portable cardiac monitoring, implantable device programming data, including cardiac event recorder, ICD, etc.) of sustained ventricular tachycardia (referring to ventricular tachycardia that affects hemodynamics and requires intervention to terminate, or ventricular tachycardia with a duration >30s) or ventricular fibrillation; iii. Have a record (ECG, Holter, bedside and portable cardiac monitoring, implantable device programming data, including cardiac event recorder, ICD, etc.) of non-sustained ventricular tachycardia (referring to continuous 3 or more ventricular rhythms, frequency >100 times/min, duration 500 times/24 hour.

Exclusion criteria

Exclusion criteria: (1) Patients with heart valve disease who have indications for surgical or interventional procedures (2) Patients who have had a myocardial infarction, stroke, unstable angina, transient ischemic attack, or hospitalization for acute heart failure within 30 days before enrollment (3) Pregnant women, women preparing for pregnancy, and breastfeeding women (4) Patients who are unable or unwilling to comply with the research protocol and complete follow-up (5) Patients with uncontrolled hyperthyroidism and hypothyroidism, severe infection, severe liver and kidney dysfunction (ALT=3 times, or/and any formula-calculated eGFR=30mL/min), malignant tumors, etc. (6) Acute or subacute infective endocarditis (7) Severe pulmonary hypertension of various causes (severe pulmonary hypertension, referring to pulmonary artery systolic pressure>70mmHg) (8) Severe electrolyte disorders, acid-base imbalance (9) Patients with known allergic reactions to adhesives or hydrogel products (10) Patients who have recently had surgical injuries, and the injury site is a possible electrode attachment site, etc., and cannot complete the electrode attachment and ECG recording (11) Patients who are participating in other clinical trials and may affect the data collection of this study (12) Other situations that the researcher believes are not suitable for enrollment (13) Combined use of other similar functional Chinese patent medicines that may affect the results of this study

Design outcomes

Primary

MeasureTime frame
Composite events of sudden cardiac death;

Secondary

MeasureTime frame
Cardiovascular death;All-cause mortality;Cardiovascular event;

Countries

China

Contacts

Public ContactJingfeng Wang

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

wjingf@mail.sysu.edu.cn+86 189 2891 6398

Outcome results

None listed

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