A Multi-Centered Randomized Double-Blinded Parallel Controlled Clinical Study on Efficacy of Warming the Kidney, Invigorating the Spleen, Activating Blood and Removing Edema Method in the Treatment of Chronic Heart Failure

Phase 1

• Conditions: chronic heart failure

• Registration Number: ITMCTR2000003867
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged between 18 to 74years;
2. Those who meet the diagnostic criteria of Western medicine;and with II to III degree of the cardiac function stardand of New York Heart Association;
3. Those whose BNP content >= 150pg/ml(or Pro-BNP >= 600pg/ml);
4. Those whose the left ventricular ejection fraction (LVEF) was <= 40%;
5. Those who meet the syndrome differentiation of TCM;
6. Those who participate in this clinical trial voluntarily, understand and sign the informed consent.

Exclusion Criteria

1. Combine the serious primary disorders;
2. Combine serious infection;
3. Plan to accept Cardiac surgical procedures;
4. Critical patients who may cannot survive to the end of the trial;
5. Pregnant or lactating women;
6. Allergic Constitution, allergic to many kinds of medicine;
7. Patients with mental disorder and unwilling to cooperate;
8. Other conditions that are not suitable for participation in clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
YHA grade;the total score of TCM syndrome;

Secondary Outcome Measures

Name	Time	Method
Plasma pro-BNP;LVEDD;EF;Kansas City Cardiomyopathy Questionnaire;LAD;6-minute walking test;Plasma BNP;Readmission rate;Minnesota heart failure quality of life score;