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Clinical Trials/ITMCTR2000002994
ITMCTR2000002994
Not yet recruiting
Phase 4

Evidence-Based Optimization and Therapeutic Mechanism of Traditional Chinese Medicine in Prevention and Treatment of Coronary Heart Disease (Angina Pectoris-Myocardial Infarction-Heart Failure)

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine0 sitesTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Acute Heart Failure
Sponsor
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

Investigators

Sponsor
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Eligibility Criteria

Inclusion Criteria

  • 1\. Clearly diagnose patients admitted to acute heart failure;
  • 2\. Aged \>\= 18 years;
  • 3\. Voluntarily participate in and sign the informed consent form;
  • 4\. Randomization can be assigned within 16 hours of admission (including outpatient, ward, ICU/CCU or emergency department).

Exclusion Criteria

  • 1\. The duration of systolic blood pressure during the screening period was less than 90mmHg.
  • 2\. It is known that hypertension patients refuse treatment, or systolic blood pressure \>\= 180mmHg, diastolic blood pressure \>\= 110mmHg after drug treatment;
  • 3\. Before entering the group, the hematocrit is less than 25%, the hemoglobin (Hgb) is less than 8\.0g / dl, or there is a history of blood transfusion within 14 days before screening, or gastrointestinal bleeding that is life\-threatening actively;
  • 4\. Body temperature \> 38 degree C (oral or equivalent) or sepsis or active infection requiring intravenous antimicrobial therapy;
  • 5\. Within 60 days before entering the group, major neurological events occurred, including cerebrovascular events.
  • 6\. Known liver injury or potentially severe liver disease (abnormal liver function) (ALT or AST \> 3 times normal, alkaline phosphatase or bilirubin \> 2 times normal);
  • 7\. Patients with known severe impairment of renal function (eGFR \< 25mL/min/1\.73m2\), or acute contrast nephropathy planned or being dialyzed or screened;
  • 8\. At present or within 30 days before entering the group, there is clinical evidence of acute coronary syndrome. (note: the diagnosis of acute coronary syndrome is a clinical diagnosis, considering that troponin concentration may significantly increase in acute heart failure, only the increase of troponin concentration is not enough to diagnose acute coronary syndrome.).
  • 9\. Acute heart failure caused by known severe arrhythmias (including any of the following: ventricular tachycardia, bradycardia with ventricular rate \< 45 beats / min, or atrial fibrillation / flutter with ventricular rate \> 120 beats / min);
  • 10\. It is known to have acute myocarditis, hypertrophic obstructive, invasive or contractile cardiomyopathy (excluding the restricted mitral filling pattern shown by Doppler echocardiography), complex congenital heart disease, constrictive pericarditis or tamponade, etc. (obvious left ventricular outflow tract obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis, or aortic valve area \< 1\.0 cm2 or previous or current echocardiography showed mean pressure difference \> 50mmhg), or severe mitral stenosis;

Outcomes

Primary Outcomes

Not specified

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