Efficacy and safety of Xin-Li-Fang in the treatment of chronic heart failure:A Randomized, double-blind, placebo-controlled study

Phase 1

• Conditions: Chronic Heart Failure

• Registration Number: ITMCTR2200005855
• Lead Sponsor: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine(Guangdong Provincial of 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)Age is above 18 years, not restrictions on male or female;
(2)Patients who meet the chronic heart failure diagnosis creteria, and have a history of chronic heart failure for more than 3 months, or clinical symptoms of heart failure for more than 3 months; The diagnosis of chronic heart failure was based on the 2018 Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in China;
(3)The syndrome differentiation of traditional Chinese medicine is the syndrome of water stopping, Qi deficiency and blood stasis;
(4)NYHA classification stage II-IV;
(5)Serum NT-proBNP>=450pg/ml;
(6)Patients have received standard medical treatment for more than 2 wks and no modification of dosage or intravenous administration has been given;
(7) To be able to and willing to provide signed informed consent.

Exclusion Criteria

(1)CHF is caused by following condition: valvular disease, congenital heart disease, pericardial disease, cardiac arrhythmia, or other non-cardiogenic factors, including dysfunction of kidney, liver and lung;
(2)Patients with severe liver, kidney, hematological disease or abnormal renal or hepatic funtion (ALT and ALP > 3 UNL, Cr> 2mg/dl(176.82umol/L), serum potassium >5.5 mmol/L. Patients with tumor, severe neural, endocrine or psychological disease; The investigator judges that the survival period does not exceed 1 year;
(3)Combined with left ventricular outflow tract obstruction, myocarditis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, aortic aneurysm, aortic dissection, congenital heart disease, and significant hemodynamic changes in patients with silent valvular heart disease; Patients with cardiogenic shock, uncontrollable malignant arrhythmia, sinus or atrioventricular block without pacemaker treatment, progressive unstable angina pectoris or acute myocardial infarction;
(4)Patients undergoing cardiac resynchronization therapy, or who will undergoing coronary revascularization or cardiac resynchronization therapy within 12 weeks;
(5)The patients with hypertension without control, SBP=180mmHg and/or DBP=110mmHg; SBP<90mmHg and/or DBP<60mmHg;
(6)People with allergies, or those who are known to be allergic to this medicine and its ingredients;
(7)Involved in any clinical trial in recent 1 month;
(8)During pregnancy and lactation women;
(9)The investigator judged that he could not complete the study or could not comply with the requirements of the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
T-proBNP;

Secondary Outcome Measures

Name	Time	Method
YHA classification;primary end point event;6 minute walking test;Minnesota living with heart failure questionnaire;TCM symptoms evaluation;Colour Sonography;