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临床试验/ITMCTR1900002608
ITMCTR1900002608尚未招募4 期

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

The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 个研究点开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
40 至 80(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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