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: 2024年4月15日

适应症

试验速览

暂无简介。

•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)

•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

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