ITMCTR2200006012
Not yet recruiting
Phase 1
Clinical observation trial of Anti-heart Failure Intelligent Formula King
Conditionschronic heart failure
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- chronic heart failure
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age: 30\-85 years old, male or female.
- •2\) Based on meeting the diagnostic criteria of western medicine for heart failure, left ventricular ejection fraction \= 50% or NT\-proBNP level \= 450 ng/L.
- •3\) Patients with TCM syndrome of yang deficiency and water stasis, qi deficiency and blood stasis.
- •4\) Requirements for medical records: chronic heart failure caused by coronary heart disease or myocardial infarction, with clinical findings of chronic heart failure for at least 3 months (the patient is in the early stage of heart failure, and the diagnosis is preferably 3\-6 months).
- •5\) Participants have New York Heart Association (NYHA) functional class of II to III and have received fixed\-dose optimal treatment for at least 2 weeks.
- •6\) Participants are volunteered to participate in this study and sign the informed consent.
Exclusion Criteria
- •1\) Patients with other types of heart failure, including heart failure caused by valve disease, congenital heart disease, pericardial disease, arrhythmia or other noncardiogenic factors.
- •2\) Possible coronary artery bypass surgery/cardiac resynchronization therapy within the next 4 weeks.
- •3\) Uncorrected primary valvular disease, left ventricular outflow obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina or acute myocardial infarction.
- •4\) Serious primary liver, kidney or blood disease or serious mental health condition or other uncontrolled systemic diseases.
- •5\) Serum creatinine level \>194\.5µM or serum potassium level \>5\.5mM.
- •6\) Alanine aminotransferase or alkaline phosphatase levels \> 1\.5 times the upper normal limit.
- •7\) Uncontrolled blood pressure, systolic blood pressure \= 180mm Hg or diastolic blood pressure \= 110mm Hg.
- •8\) Lactating or pregnant women.
- •9\) Known or suspected of being allergic to the study drug.
- •10\) Received another study drug within 30 days before randomization.
Outcomes
Primary Outcomes
Not specified
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