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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002822

Enrollment

Unknown

Registered

2019-12-10

Start date

2017-01-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coexisting Acute Heart Failure and Airway Stenosis

Interventions

Group 1:Standardized treatment of acute heart failure + aminophylline to improve airway stenosis

Group 3:modified conventional therapy +intravenous drip of SFI

Group 2:Standardized treatment of acute heart failure + Inhaled or intravenous corticosteroids to improve airway stenosis

Eligibility

Sex/Gender

All

Age

41 Years to 85 Years

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
NT-proBNP;TCM syndrome integral;Quantification of airway stenosis control level;	—

Secondary

Measure	Time frame
TCM syndrome efficacy index;	—

Countries

China

Contacts

Public ContactXu Wang

njzyydx@126.com+86 18051986182

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026