A randomized controlled trial for Shenfu Injection Combined with Corticosteroids Therapy for Coexisting Acute Heart Failure and Airway Stenosis

Phase 1

Completed

• Conditions: Coexisting Acute Heart Failure and Airway Stenosis

• Registration Number: ITMCTR1900002822
• Lead Sponsor: The Affiliated Huai'an Hospital of Xuzhou Medical University and The Second People's Hospital of Huai'an

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The subjects participated in the study voluntarily and signed the informed consent;
2. Aged between 20 and 40 years old;
3. Patients with coexisting acute heart failure (AHF) and airway stenosis (AS): the diagnostic criteria were according to the 2016 European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of AHF and chronic heart failure and the Chinese guidelines for the diagnosis and treatment of AHF 2010. The primary disease was coronary heart disease, and the clinical manifestations of AS must coexist;
4. Patients with Yang-Qi deficiency syndrome: the diagnostic criteria were according to the Guidance Principle of the Clinic Research of New Traditional Chinese and Diagnosis and Treatment Technology of Emergency Chinese and Western Medicine.

Exclusion Criteria

1. AHF due to acute myocardial infarction;
2. AHF due to other diseases (valvular heart disease, congenital heart disease, pericardial disease, arrhythmia, other non cardiac causes);
3. AHF due to myocarditis;
4. AHF due to pulmonary embolism;
5. Complicated with uncontrolled serious arrhythmia;
6. Complicated with severe peptic ulcer;
7. Serious liver, kidney, blood system, mental disease or systemic disease;
8. Significant liver and kidney dysfunction (ALT > 2.0 times the upper limit of normal value; creatinine > 1.5 times the upper limit of normal value);
9. Serum potassium > 5.5mmol/l;
10. Pregnant or lactating women;
11. Allergic to Shenfu injection (SFI).

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-proBNP;TCM syndrome integral;Quantification of airway stenosis control level;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome efficacy index;