Effect of Shenfu injection on hemodynamics and clinical efficacy in patients with cardiogenic shock in acute decompensation of chronic heart failure due to coronary heart disease: a multicenter, randomized, double-blinded, parallel placebo-controlled trial

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Aged 40 and 80 years;
2. Meet the diagnostic criteria of coronary heart disease;
3. Meet the diagnostic criteria of acute decompensation of chronic heart failure;
4. Meet the diagnostic criteria of cardiogenic shock;
5. NYHA classification between III to IV;
6. Under the use of norepinephrine, PiCCO showed that MAP>65mmHg, but GEF<25% or CI<3.0L/min/m2, while PVPI<1.2;
7. Voluntarily signed the written informed consent form.

Exclusion Criteria

1. Patients with chronic heart failure who are not due to coronary heart disease;
2. Patients with any of the following diseases:
(1) Acute myocarditis;
(2) Hypertrophic obstructive cardiomyopathy;
(3) Uncontrolled malignant arrhythmias;
(4) Severe valvular heart disease requiring surgical treatment;
(5) Uncontrolled blood pressure ( SBP>=180mmHg and/or DBP>=110mmHg );
(6) Pulmonary artery embolism;
(7) Other diseases that may affect the evaluation of the efficacy and safety of experimental drugs;
3. Patients using intra-aortic balloon counterpulsation;
4. Aggravation of heart failure caused by digitalis poisoning;
5. Diabetic patients with poor blood glucose control within 24 hours before randomization;
6. Accompany by severe primary diseases in liver, renel, hematopoietic system, etc. Or severe disfunction of liver or renel;
7. Pregnant or lactating women;
8. Drug dependence or mental illness;
9. Participating in other clinical trials within nearly three month;
10. Allergy to Shenfu injection, or allergic constitution;
11. To be judged by the researchers that the patient is not appropriate to take part in the clinical trial.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PiCCO parameters (GEF, CI, ELWI, GEDI, SVRI, etc.);Incidence of cardiovascular composite end-point events at 28 and 90 days (cardiovascular death, abandon treatment due to deterioration of heart failure, successful resuscitation after cardiac arrest, malignant arrhythmia, re-hospitalization in ICU/CCU because of aggravated heart failure);

Secondary Outcome Measures