Clinical observation trial of Anti-heart Failure Intelligent Formula King

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

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.
11) Unwilling or unable to provide written consent.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-proBNP;six-minute walk test;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome score;electrocardiography;minnesota heart failure quality of life questionnaire;left ventricular ejection fraction;left ventricular end diastolic dimension;blood pressure;New York Heart Association (NYHA) functional classification;