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Clinical efficacy evaluation study of Guanxinning tablets in the prevention and treatment of coronary heart disease combined with heart failure

Clinical efficacy evaluation study of Guanxinning tablets in the prevention and treatment of coronary heart disease combined with heart failure

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000980
Enrollment
Unknown
Registered
2025-05-13
Start date
2024-11-20
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Coronary heart disease combined with heart failure

Interventions

Trial group:Conventional treatment + Guanxin Ning tablets
Control group:Routine treatment

Sponsors

Xiuyan Manchu Autonomous County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria for coronary heart disease 2. meet the diagnostic criteria for chronic heart failure; 3. be between 18 and 80 years of age both male and female; 4.Voluntarily participate in this trial and sign an informed consent form

Exclusion criteria

Exclusion criteria: 1. severe primary hypertension (seated systolic blood pressure >= 180 mmHg and/or seated diastolic blood pressure >= 110 mmHg) but poorly controlled by medication malignant hypertension hypertensive emergencies hypertensive crises and hypertensive encephalopathy; known secondary hypertension; 2. Admission to the hospital for exacerbation of heart failure within 4 weeks before enrollment and confirmed by records; myocardial infarction or coronary artery revascularization within 2 months before enrollment; paroxysmal atrial fibrillation persistent atrial fibrillation persistent atrial fibrillation for more than 1 year within 4 weeks before enrollment and the condition of the above three kinds of atrial fibrillation is still not stabilized after treatment permanent atrial fibrillation or atrial flutter; 3. Combination of other heart diseases: pulmonary heart disease pre-coronary heart disease moderate to severe pulmonary hypertension moderate to severe stenosis or closure insufficiency of heart valves cardiomyopathy and patients with heart failure caused by cardiac arrhythmia; episodes of tachycardia (except for sinus tachycardia) or cardiogenic shock unstable angina pectoris and the presence of uncontrollable malignant cardiac arrhythmia; those who have undergone cardiothoracic surgery (except for those who have had coronary artery bypass grafting surgery) and those who have a subject with planned to undergo left ventricular remodeling surgery history of previous heart transplantation or planned heart transplantation; 4. active tuberculosis; 5. autoimmune diseases such as systemic lupus erythematosus giant cell myocarditis; 6. Serious diseases affecting their survival (e.g. tumors etc.) and psychiatric illnesses with poor control and drug addicts who are not detoxified; 7. Excessive obesity body mass index (BMI) > 30kg/m^2; 8. Serious hepatic and renal dysfunction; GFR<=30ml/(min-1.73m^2)); 9. use of other blood-activating and blood-stasis-removing traditional Chinese medicines with specific combinations based on the actual clinical needs of the investigator; 10. Patients with known allergy to the study drug (including its constituent ingredients); 11. Those with pregnancy plan or pregnant or lactating women or those who cannot guarantee effective contraception during the trial period; 12. patients who have participated in other clinical trials within the last 3 months; 13.Patients who in the opinion of the investigator have factors that make them unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
echocardiography;

Secondary

MeasureTime frame
Serum non-targeted metabolomics;Six-minute walk test;N-terminal pro-B-type natriuretic peptide;Angina symptom score;Fecal 16s rDNA/Metagenomics;New York Heart Association Functional Classification;

Countries

China

Contacts

Public ContactWang Yu

Xiuyan Manchu Autonomous County Central People's Hospital

1459471692@qq.com13889739604

Outcome results

None listed

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