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Clinical study and targeted metabolomics of Yixintong capsule for the treatment of cardiac insufficiency after acute myocardial infarction

Registration number：

ITMCTR2025000604

Date of Last Refreshed on：

2025-03-27

Date of Registration：

2025-03-27

Registration Status：

Prospective registration

Public title：

Clinical study and targeted metabolomics of Yixintong capsule for the treatment of cardiac insufficiency after acute myocardial infarction

English Acronym：

Scientific title：

Clinical study and targeted metabolomics of Yixintong capsule for the treatment of cardiac insufficiency after acute myocardial infarction

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jixu Li

Study leader：

Wei Li

Applicant telephone：

17864190744

Study leader's telephone：

17662373876

Applicant Fax：

Study leader's fax：

Applicant E-mail：

17864190744@163.com

Study leader's E-mail：

liw1013@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.216 Yingxuan Street Tai'an City Shandong Province

Study leader's address：

No.216 Yingxuan Street Tai'an City Shandong Province

Applicant postcode：

271000

Study leader's postcode：

271000

Applicant's institution：

Tai'an Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

TAZYEC-02-2024-12-09

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Tai'an Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/12/26 0:00:00

Contact Name of the ethic committee：

Guangyuan Meng

Contact Address of the ethic committee：

No.216 Yingxuan Street Tai'an City Shandong Province

Contact phone of the ethic committee：

15269880841

Contact email of the ethic committee：

601941706@qq.com

Primary sponsor：

Tai'an Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No.216 Yingxuan Street Tai'an City Shandong Province

Secondary sponsor：

Country：

China

Province：

Shandong Province

City：

Tai'an city

Institution
hospital：

Tai'an Hospital of Traditional Chinese Medicine

Address：

No.216 Yingxuan Street Tai'an City Shandong Province

Source(s) of funding：

Tai'an Hospital of Traditional Chinese Medicine

I50

Target disease：

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：

By studying the clinical efficacy of Yixintong Capsules in patients with heart failure after acute myocardial infarction and its targeted metabolomics this research aims to explore the role of traditional Chinese medicine in improving cardiac function after acute myocardial infarction reducing the incidence of major adverse cardiovascular events (MACE) and alleviating patients' clinical symptoms. The findings will provide new clinical data for practical applications and seek safer and more effective treatment options.

Description for medicine or protocol of treatment in detail：

**Control Group:** Patients received conventional Western medicine treatment including: - **Aspirin enteric-coated tablets** (50 mg) orally once daily one tablet per dose. - **Ticagrelor tablets** (90 mg) orally twice daily one tablet per dose. - **Atorvastatin calcium tablets** (20 mg) orally once daily one tablet per dose. - **Metoprolol succinate sustained-release tablets** (47.5 mg) starting at 11.875 mg per dose orally once daily. The dosage was adjusted based on blood pressure and heart rate with a maximum dose of one tablet (47.5 mg) once daily. - **Furosemide tablets** (20 mg) orally once daily one tablet per dose. - **Spironolactone tablets** (20 mg) orally once daily one tablet per dose. - **Sacubitril/valsartan tablets** (*Novartis Pharmaceuticals Corporation* 50 mg) starting at 25 mg per dose orally twice daily. The dosage was adjusted based on blood pressure with a maximum dose of two tablets (50 mg each) twice daily. **Treatment Group:** On the basis of the control group patients additionally received **Yixintong Capsules** (*prepared by Tai'an Traditional Chinese Medicine Hospital*; specification: 0.39 g per capsule; approval number: Luyaozhi Z09080083). The main ingredients include *Panax notoginseng (Sanqi) Red ginseng Salvia miltiorrhiza (Danshen) Astragalus membranaceus (Huangqi) Dalbergia odorifera (Jiangxiang) Pueraria lobata (Gegen) Bitter orange (Zhike) Hirudo (Shuizhi) Earthworm (Dilong) Dried tangerine peel (Chenpi) Ligusticum chuanxiong (Chuanxiong) Corydalis yanhusuo (Yanhusuo) Ophiopogon japonicus (Maidong) and Spatholobus suberectus (Jixueteng).* - **Dosage:** Four capsules per dose three times daily. All medications were provided by the **Western and Traditional Chinese Medicine Pharmacy of Tai'an Traditional Chinese Medicine Hospital** ensuring a fixed source. The treatment duration for both groups was **12 weeks** with comparisons of various indicators before and after treatment.

Inclusion criteria

1) Patients who meet the diagnostic criteria for heart failure after acute myocardial infarction; 2) Patients who meet the diagnostic criteria for traditional Chinese medicine syndromes of Qi deficiency and blood stasis; 3) Age between 40 and 80 years regardless of gender; 4) Left ventricular ejection fraction (LVEF) < 50%; 5) Killip classification I (with left heart failure lung rales affecting < 50% of lung fields) to III (acute pulmonary edema dry rales in the whole lung and large medium and small wet rales); 6) No contraindications to the study medication and willing to sign an informed consent form.

Exclusion criteria：

1) Patients with restrictive cardiomyopathy dilated cardiomyopathy rheumatic heart disease hypertrophic (obstructive) cardiomyopathy uncorrected primary valvular disease myocarditis or malignant arrhythmias; 2) Patients with liver and kidney dysfunction malignant tumors autoimmune diseases or hematological disorders; 3) Patients with cardiogenic shock systolic blood pressure < 100 mmHg or severe infections; 4) Patients with allergies to multiple drugs or those with allergic constitutions; 5) Pregnant or breastfeeding women; 6) Patients who have participated in other clinical trials within the past 2 months or have taken other traditional Chinese medicine decoctions within the past 2 weeks.

Study execute time：

From 2025-02-01

To      2027-02-01

Recruiting time：

From 2025-03-31

To      2026-12-01

Interventions：

30

Group：

Treatment group

Sample size：

Intervention：

Conventional western medicine combined with Yixintong capsule therapy

Intervention code：

30

Group：

Control group

Sample size：

Intervention：

Conventional Western Anti-Heart Failure Therapy

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Shandong Province

City：

Tai'an city

Institution/hospital：

Tai'an Hospital of Traditional Chinese Medicine

Level of the institution：

grade 3A

Outcomes：

Outcome：

Electrolyte

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

MLHFQ Quality of Life Score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Urine volume

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Urinalysis

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Weight

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

6 minutes walking distance

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood routine examination

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

NT-proBNP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Chinese Medicine Score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

LVEDD

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

LVESD

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Renal function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Lee's Heart Failure Score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Stool-RT

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Breathe

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

LVEF

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Heart rate

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Liver function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

40
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The third-party statistician used SPSS statistical software to generate the randomization scheme using the random number table method.

Blinding：

IPD sharing：

Yes

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

2027-6(Through Google Drive or Dropbox file-sharing services.)

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

1. **Data Collection** - **Collection Tools**: Use of electronic medical records (EMR) systems clinical databases questionnaires laboratory test data and imaging data etc. - **Collection Timepoints**: Define the time points for data collection such as baseline mid-treatment and post-treatment (e.g. at the end of each treatment cycle 12 weeks later etc.). - **Data Types**: Includes clinical data (e.g. basic information symptom scores cardiac function scores medication records) laboratory test data (e.g. electrocardiogram echocardiogram blood biochemistry etc.). 2. **Data Management** - **Data Storage**: Data can be stored using a secure electronic storage platform (ResMan) ensuring data security integrity and privacy protection. - **Data Backup**: Regular data backups to ensure data can be restored in the event of loss or damage. - **Data Access**: Access to data is restricted and only authorized research personnel or staff are allowed to view and modify data. - **Data Quality Control**: Implement data quality control processes to ensure the accuracy and consistency of the data such as through double entry automated checks etc. to reduce input errors. 3. **Ethics and Compliance** - Ensure that data collection and management comply with the requirements of the ethics committee and adhere to relevant privacy protection regulations. - Patients must sign an informed consent form prior to the study clearly indicating the purpose of data collection and the protective measures in place.

Data Managemen Committee：

Not yet

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

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