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Clinical Pharmacological Evaluation of Guanxinning Tablets in the Treatment of Coronary Heart Disease with Concomitant Heart Failure

Clinical Pharmacological Evaluation of Guanxinning Tablets in the Treatment of Coronary Heart Disease with Concomitant Heart Failure

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095860
Enrollment
Unknown
Registered
2025-01-14
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-27

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

Sponsors

Dongyang 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;N-terminal B-type pronatriuretic peptide;New York College of Cardiology Heart Function Classification;6-minute walk test;Angina Symptom;

Secondary

MeasureTime frame
Serum untargeted metabolomics;Fecal 16S rDNA/Metagenomics;

Countries

China

Contacts

Public ContactLu Liang

Dongyang People's Hospital

dy-lu@163.com+86 138 5897 3439

Outcome results

None listed

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