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Clinical Trials/ITMCTR2200006012
ITMCTR2200006012
Not yet recruiting
Phase 1

Clinical observation trial of Anti-heart Failure Intelligent Formula King

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.

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

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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