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Real World Study of Yiqifumai Prescription in Treating Heart Failure

Registration number：

ITMCTR2024000124

Date of Last Refreshed on：

2024-07-14

Date of Registration：

2024-07-14

Registration Status：

Prospective registration

Public title：

Real World Study of Yiqifumai Prescription in Treating Heart Failure

English Acronym：

Real World Study of Yiqifumai in HF

Scientific title：

Real World Study of Yiqifumai Prescription in Treating Heart Failure

Scientific title acronym：

Real World Study of Yiqifumai in HF

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Shichao Lv

Study leader：

Shichao Lv

Applicant telephone：

13920127740

Study leader's telephone：

13920127740

Applicant Fax：

Study leader's fax：

Applicant E-mail：

372272027@qq.com

Study leader's E-mail：

372272027@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Tianjin 88 Changling Road

Study leader's address：

Tianjin 88 Changling Road

Applicant postcode：

300193

Study leader's postcode：

300193

Applicant's institution：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

TYLL2024[Z]字039

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of The First Teaching Hospital of Tianiin University of TCM

Date of approved by ethic committee：

2024/6/19 0:00:00

Contact Name of the ethic committee：

IRB of The First Teaching Hospital of Tianiin University of TCM

Contact Address of the ethic committee：

Tianjin 88 Changling Road

Contact phone of the ethic committee：

022-27986258

Contact email of the ethic committee：

yfyiec@163.com

Primary sponsor：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Primary sponsor's address：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Secondary sponsor：

Country：

China

Province：

Tianjin

City：

TianJin

Institution
hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address：

Tianjin 88 Changling Road

Source(s) of funding：

self-raising

Target disease：

heart failure

Target disease code：

Study type：

Observational study

Study design：

Case study

Study phase：

Retrospective study

Objectives of Study：

To obtain the clinical characteristics and combined medication rules of Yiqi Fumai prescription in treating patients with heart failure in the real world, so as to provide reference for relevant clinical rational and effective drug use, and improve the prevention, treatment and rehabilitation system of heart failure.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Meet the diagnostic criteria for heart failure; Age ≥18 years old, gender unlimited; NYHA cardiac function Grade II to IV

Exclusion criteria：

1.Complicated with acute myocardial infarction (within 2 months), constrictive pericarditis, acute cerebrovascular accident, acute myocarditis, cardiogenic shock, congenital heart disease, primary severe valvular disease, symptomatic hypotension, severe arrhythmia and hemodynamic changes; 2.There are serious endocrine diseases such as malignant tumor, severe hepatic and renal insufficiency, primary disease of blood system, or diabetes with serious complications, hyperthyroidism, etc.

Study execute time：

From 2024-08-01

To      2024-12-31

Recruiting time：

From 2024-08-01

To      2024-12-31

Interventions：

1500

Group：

YQFM group

Sample size：

Intervention：

Yiqifumai injection

Intervention code：

Total sample size ： 1500

Countries of recruitment
and research settings：

Country：

China

Province：

Tianjin

City：

Tianjin

Institution/hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Class-A Grade-3

Outcomes：

Outcome：

the dosage of YQFM

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Inpatient department

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

CRP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

LVEDD

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Diagnosis

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Liver function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Readmissions within 1 year

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Baseline Characterization

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Admission condition

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

BNP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

FS

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

the administration of YQFM

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

LVESD

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Renal function

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

LVEF

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

the solvent of YQFM

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

admission to hospital

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Electrocardiogram

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

the combination medications of YQFM

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Solar term

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Not applicable.

Blinding：

IPD sharing：

No

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

Not shared

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

The patients' personal basic information, such as name, age, gender, smoking history, drinking history, permanent residence, medical insurance type, etc. were collected through the medical record system, and the patients' personal privacy information (such as name, hospital medical record number, ID number, etc.) was desensitized. Collect relevant disease information of patients according to admission records, course records, discharge records, and doctor's order information in the inpatient medical record system. Hospitalization conditions include admission condition, admission method, inpatient departments, solar terms, length of stay, Western medicine diagnosis, traditional Chinese medicine diagnosis, treatment outcome, etc. The patient's vital signs (mean arterial pressure, respiratory rate, pulse), laboratory tests (liver function, kidney function, C-reactive protein) and functional test data (left ventricular ejection fraction, ventricular wall thickness, electrocardiogram, etc.) were included. The completed case report form was reviewed by the monitor and returned to the research group for data processing. The data of the case report form shall be entered in two copies by two persons, and the database shall be locked after verification and confirmation.

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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