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

Registration number：

ITMCTR2200005855

Date of Last Refreshed on：

2022-04-13

Date of Registration：

2022-04-13

Registration Status：

Prospective registration

Public title：

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

English Acronym：

XLF-CHF

Scientific title：

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

Scientific title acronym：

XLF-CHF

Study subject ID：

SZ2021ZZ41

The registration number of the Partner Registry or other register：

ChiCTR2200058649 ; ChiMCTR2200005855

Applicant：

Tong Liu

Study leader：

Xiankun Chen

Applicant telephone：

+86 13808866031

Study leader's telephone：

+86 13808890239

Applicant Fax：

Study leader's fax：

Applicant E-mail：

40073217@qq.com

Study leader's E-mail：

chenxiankun232323@126.com

Study leader's website(voluntary supply)：

http://www.gdhtcm.com/

Study leader's website
(voluntary supply)：

Applicant address：

Department of Cardiology, Ersha branch of Guangdong Provincial Hospital of Chinese Medicine, No. 261 Datong Road, Yuexiu District, Guangzhou, Guangdong

Study leader's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Applicant postcode：

510000

Study leader's postcode：

510000

Applicant's institution：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine（Guangdong Provincial of Chinese Medicine）

Approved by ethic committee：

Approved No. of ethic committee：

BF2021-261-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Provincial of Chinese Medicine

Date of approved by ethic committee：

2022/1/7 0:00:00

Contact Name of the ethic committee：

Xiaoyan Li

Contact Address of the ethic committee：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Contact phone of the ethic committee：

+86 020-81887233-35943

Contact email of the ethic committee：

llbgs@gzucm.edu.cn

Primary sponsor：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine（Guangdong Provincial of Chinese Medicine）

Primary sponsor's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine（Guangdong Provincial of Chinese Medicine）

Address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Source(s) of funding：

State Key Laboratory of Dampness Syndrome of Chinese Medicine

Target disease：

Chronic Heart Failure

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To evaluate the efficacy and safety of Xin-Li-Fang for chronic heart failure, and provide high quality evidence for its clinical application.

Description for medicine or protocol of treatment in detail：

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 execute time：

From 2021-07-01

To      2023-07-01

Recruiting time：

From 2022-04-01

To      2023-07-01

Interventions：

30

Group：

Xin-Li-Fang group

Sample size：

Intervention：

Basal treatment (ACEI or ARB/β-blockers/diuretics/with or without digoxin)+Xin-Li-Fang Granule

Intervention code：

30

Group：

Placebo Group

Sample size：

Intervention：

Basal treatment (ACEI or ARB/β-blockers/diuretics/with or without digoxin)+Placebo

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine（Guangdong Provincial of Chinese Medicine）

Level of the institution：

Class A tertiary hospital

Outcomes：

Outcome：

NT-proBNP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

NYHA classification

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

primary end point event

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

6 minute walking test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Minnesota living with heart failure questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM symptoms evaluation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Colour Sonography

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Adverse events and adverse reactions

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Safety Evaluation

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

coating on the tongue

Tissue：

Fate of sample 

Preservation after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Preservation after use

Note：

Sample Name：

Urine

Tissue：

Fate of sample 

Preservation after use

Note：

Sample Name：

faeces

Tissue：

Fate of sample 

Preservation after use

Note：

Not yet recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Stratified random assignment operation, clinical research methodology personnel used SAS 9.2 software to complete the programming and randomization operation. Publish the random distribution results through the network central random distribution system.

Blinding：

The researchers, subjects and result measurers will blinding

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Please call or email the project contact person and person in charge to ask for the original data

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

After the original data is recorded in CRF form, the data entry clerk uses EpiData software to collect the research data.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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