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Effect of modified Yiqi Huoxue therapy on patients with heart failure with preserved ejection fraction

Registration number：

ITMCTR2100004908

Date of Last Refreshed on：

2021-06-01

Date of Registration：

2021-06-01

Registration Status：

Retrospective registration

Public title：

Effect of modified Yiqi Huoxue therapy on patients with heart failure with preserved ejection fraction

English Acronym：

Scientific title：

Effect of modified Yiqi Huoxue therapy on patients with heart failure with preserved ejection fraction

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100046951 ; ChiMCTR2100004908

Applicant：

Wang Yu

Study leader：

Wang Yu

Applicant telephone：

+86 13671182721

Study leader's telephone：

+86 13671182721

Applicant Fax：

Study leader's fax：

Applicant E-mail：

rongxuewuhen000@126.com

Study leader's E-mail：

rongxuewuhen000@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

18 Heping Lane North, Dongcheng District, Beijing, China

Study leader's address：

18 Heping Lane North, Dongcheng District, Beijing, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing Hepingli hospital

Approved by ethic committee：

Approved No. of ethic committee：

2018-07

Approved file of Ethical Committee：

Name of the ethic committee：

Medical Ethics Committee of Beijing Hepingli hospital

Date of approved by ethic committee：

2018/2/2 0:00:00

Contact Name of the ethic committee：

Dong Yantong

Contact Address of the ethic committee：

18 Heping Lane North, Dongcheng District, Beijing, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Beijing Hepingli Hospital

Primary sponsor's address：

18 Heping Lane North, Dongcheng District, Beijing, China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Dongcheng District

Institution
hospital：

Beijing Dongcheng District Municipal health Commission

Address：

83 Forty-First Lane East

Source(s) of funding：

Beijing Hepingli hospital

Target disease：

Heart Failure with preserved Ejection Fraction,HFpEF

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

On the basis of conventional Yiqi Huoxue therapy (a therapeutic principle with Chinese medicine for reinforcing Qi and activating blood circulation), Rhodiola was added to form the modified therapy of Yiqi Huoxue and then we designed the study to investigate the efficacy of modified Yiqi Huoxue therapy in patients with heart failure with preserved ejection fraction (HFpEF).

Description for medicine or protocol of treatment in detail：

Inclusion criteria

The diagnosis of HFPEF was based on the 2018 Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in China. Main diagnostic criteria: 1. Symptoms: dyspnea, fatigue, edema of lower limbs; 2. Signs: rales in the lungs, tachypnea, swollen jugular vein, enlarged liver; 3. Auxiliary examination: echocardiography revealed enlarged heart, abnormal cardiac function, and elevated plasma levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP). However, the Left Ventricle Eject Fraction (LVEF) >= 50%.

Exclusion criteria：

Patients with hyperthyroidism, renal disease, tumor, recent urinary tract infection, short-term systemic infection, and pregnancy.

Study execute time：

From 2018-10-01

To      2019-09-30

Recruiting time：

From 2018-11-01

To      2019-07-01

Interventions：

76

Group：

Control group

Sample size：

Intervention：

conventional western medicine treatment

Intervention code：

83

Group：

Treatment group

Sample size：

Intervention：

modified Yiqi Huoxue therapy combined with conventional western medicine treatment

Intervention code：

Total sample size ： 159

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Dongcheng District

Institution/hospital：

Beijing Hepingli Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

6 Minute Walk Distance, 6MWD

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Left Atrial Diameter, LAD

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

heart rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

E/A

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood pressure

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Left Ventricular End-diastolic Dimension, LVEDD

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

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)：

The researchers stratified the subjects according to their characteristics, such as age, sex, body mass index, etc., and then randomly assigned the subjects to the treatment group and the control group within each stratification.

Blinding：

Not stated

IPD sharing：

Yes

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

ResMan, http://www.medresman.org.cn.

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

Executive researchers would take charge of Data collection and Management, supervised by Study leader

Data Managemen Committee：

No

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

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