Combined treatment of heart failure after coronary heart disease

ISRCTN ISRCTN16538701
DOI https://doi.org/10.1186/ISRCTN16538701
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Ms Lan Hai
Public, Scientific, Principal Investigator

No.105 Jianshe Road
Tianshui City
741000
China

ORCiD logoORCID ID 0009-0004-7642-1378
Phone +86-18193837516
Email hanlan_lher@163.com

Study information

Study designSingle center randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleClinical effect observation of Sacubitril/valsartan combined with Qili cardiotonic capsule on patients with heart failure after coronary heart disease
Study acronymCEOSVQLC
Study objectivesThe 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) studiedCombined treatment of heart failure after coronary heart disease
Intervention106 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 typeDrug
Pharmaceutical study type(s)Pharmacodynamic
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Sacubitril/valsartan, Qili cardiotonic capsule
Primary outcome measure1. N-terminal pro-brain natriuretic peptide (NT-proBNP) is measured using immunoassay at baseline and at 6 months
2. 6-minute walking distance is measured using the 6-minute walking test (6MWT) at baseline and at 6 months
3. Left ventricular ejection fraction (LVEF) is measured using echocardiography at baseline and at 6 months
4. Left ventricular end-systolic diameter (LVESD) is measured using echocardiography at baseline and at 6 months
5. Left ventricular end-diastolic diameter (LVEDD) is measured using echocardiography at baseline and at 6 months
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/10/2022
Completion date01/04/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit55 Years
Upper age limit80 Years
SexBoth
Target number of participants106
Total final enrolment106
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2022
Date of final enrolment31/08/2024

Locations

Countries of recruitment

  • China

Study participating centre

Tianshui Hospital of Traditional Chinese Medicine
Near the intersection of Nanming Road and Jiehe North Road in Zhongcheng Street
Tianshui City
741000
China

Sponsor information

Tianshui Hospital of Traditional Chinese Medicine
Hospital/treatment centre

Near the intersection of Nanming Road and Jiehe North Road in Zhongcheng Street
Tianshui City
741000
China

Phone +86-09388212475
Email mayupeng@21cn.com
Website https://tszyyy.cn/

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/05/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanner publication in a peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
hanlan_lher@163.com

Editorial Notes

16/05/2025: Trial's existence confirmed by the Ethics Committee of Tianshui Traditional Chinese Medicine Hospital.