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临床试验/NL-OMON55484
NL-OMON55484招募中4 期

Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands - DECISIO

niversitair Medisch Centrum Groningen0 个研究点目标入组 982 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
982

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • 1. Age >=18 years
  • 2. Outpatients with chronic HF, NYHA II - ambulatory IV
  • 3. LVEF<=50%
  • 4. Serum NT-proBNP concentrations
  • - Previous HF hospitalization <= 1 year: >=400pg/mL if sinus rhythm; >=800pg/mL
  • - Previous HF hospitalization > 1 year or in the absence of HF hospitalization:
  • >=600pg/mL if sinus rhythm; >=1000pg/mL if AF
  • 5. >=14 days stable on guideline-recommended therapy (doses and number of
  • therapies as tolerated by each patient)

排除标准

  • 1. Heart rate <=60bpm (if sinus rhythm); heart rate <=70bpm (if AF)
  • 2. History of HF hospitalization <=7days
  • 3. History of myocardial infarction, myocarditis, percutaneous intervention,
  • RCT, pacemaker/ICD implantation, cardiac surgery or stroke <=30 days
  • 4. Estimated glomerular filtration rate (eGFR), <=30ml/min/1.73m2
  • 5. The presence of a mechanical assist device
  • 6. Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
  • 7. Scheduled for mechanical assist device or heart transplantation
  • 8. Other non-cardiac conditions with limited life expectancy
  • 9. Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
  • 10. Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)
  • 11. (Intermittent) complete heart block or second-degree AV block type Mobitz
  • without pacemaker
  • 12. Severe (grade III/III) aortic valve disease
  • 13. Complex congenital heart disease
  • 14. Proven hypersensitivity to digoxin
  • 15. Concomitant medication that interact with digoxin
  • 16. Use of digoxin <=6 months prior to inclusion
  • 17. Participation in another clinical trial (registry studies not included)
  • 18. Women who are pregnant, breastfeeding or may be considering pregnancy
  • during the study period

研究者

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