Combined treatment of heart failure after coronary heart disease
| ISRCTN | ISRCTN16538701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16538701 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Tianshui Hospital of Traditional Chinese Medicine |
| Funder | Investigator initiated and funded |
- Submission date
- 15/05/2025
- Registration date
- 20/05/2025
- Last edited
- 19/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Qili cardiotonic capsule and Sacubitril/valsartan are commonly used drugs for the treatment of heart failure. The single drug treatment effect and prognosis are poor, and the combination of traditional Chinese and Western medicine can play the role of treating both symptoms and root causes. However, there are few studies on the combined treatment of heart failure at home and abroad. Therefore, this study took patients with heart failure after coronary heart disease as the research object, and explored the therapeutic effect of Qili cardiotonic capsule combined with Sacubitril/valsartan and its effect on NT-proBNP level.
Who can participate?
Patients with coronary heart disease and heart failure. The results showed that there were 33 males and 20 females in the experimental group, with an average age of 68.89 ± 10.60 years. There were 27 males and 23 females in the control group, with an average age of 68.30 ± 11.44 years.
What does the study involve?
The control group was treated with Sacubitril/valsartan orally, and the experimental group was treated with Sacubitril/valsartan combined with Qili cardiotonic capsule.
What are the possible benefits and risks of participating?
The combination of Sacubitril/valsartan and Qili cardiotonic capsule was more effective in the treatment of patients with coronary heart disease complicated with heart failure，it can improve cardiac function in a short period of time.
Where is the study run from?
This study was conducted at Tianshui Hospital of Traditional Chinese Medicine (China)
When is the study starting and how long is it expected to run for?
This study was starting on October 1, 2022 and ending on April 1, 2025.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Lan Hai , hanlan_lher@163.com
Contact information
Public, Scientific, Principal investigator
No.105 Jianshe Road
Tianshui City
741000
China
 ORCID ID |
0009-0004-7642-1378 |
|---|---|
| Phone | +86-18193837516 |
| hanlan_lher@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single center randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical effect observation of Sacubitril/valsartan combined with Qili cardiotonic capsule on patients with heart failure after coronary heart disease |
| Study acronym | CEOSVQLC |
| Study objectives | The combination of Sacubitril/valsartan and Qili cardiotonic capsule was more effective in the treatment of patients with coronary heart disease complicated with heart failure, and can improve cardiac function in the short term. |
| Ethics approval(s) |
Approved 10/04/2025, the Ethics Committee of Tianshui Traditional Chinese Medicine Hospital (Near the intersection of Nanming Road and Jiehe North Road in Zhongcheng Street, Tianshui City, 741000, China; +86-09388212475; mayupeng@21cn.com), ref: TSSZY2025-LY004-04 |
| Health condition(s) or problem(s) studied | Combined treatment of heart failure after coronary heart disease |
| Intervention | 106 patients with coronary heart disease and heart failure were randomly divided into control group and experimental group by simple random grouping method, 53 cases in each group.The control group was treated with Sacubitril/valsartan orally, and the experimental group was treated with Sacubitril/valsartan combined with Qili cardiotonic capsule. Both groups were followed up for 6 months. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sacubitril/valsartan, Qili cardiotonic capsule |
| Primary outcome measure(s) |
1. N-terminal pro-brain natriuretic peptide (NT-proBNP) is measured using immunoassay at baseline and at 6 months |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 55 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 106 |
| Total final enrolment | 106 |
| Key inclusion criteria | 1. Meeting the 2021 European Society of Cardiology diagnostic criteria and treatment guidelines for acute and chronic heart failure; 2. The heart failure classification conformed to the New York Heart Association (NYHA) cardiac function classification II-IV; 3. Chronic heart failure with coronary heart disease. |
| Key exclusion criteria | 1. Combined with other cardiovascular diseases leading to heart failure, such as severe valvular disease, malignant arrhythmia, acute myocarditis, acute myocardial infarction, various types of cardiomyopathy, malignant hypertension 2. Complicated with severe liver, kidney, lung or other important organ dysfunction 3. Combined with malignant tumor; severe anemia requiring blood transfusion 4. Patients who could not complete all follow-ups 5. Patients who did not test blood routine within 24 hours of hospitalization |
| Date of first enrolment | 01/12/2022 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Tianshui City
741000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. hanlan_lher@163.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/05/2025: Trial's existence confirmed by the Ethics Committee of Tianshui Traditional Chinese Medicine Hospital.
