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

Department of Cardiology, Hartcentrum, University Medical Center Groningen0 个研究点目标入组 982 人开始时间: 2019年1月8日最近更新: 2021年3月22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 before randomisation =400pg/mL if sinus rhythm; =800pg/mL if AF
•Previous HF hospitalization > 1 year before randomisation or in the absence of (recent) HF hospitalizations = 600pg/mL if sinus rhythm; =1000 pg/mL if AF
•BNP concentrations:
•Previous HF hospitalization = 1 year before randomisation =100pg/mL if sinus rhythm; =200pg/mL if AF
•Previous HF hospitalization > 1 year before randomisation or in absence of (recent) HF hospitalization =150pg/mL if sinus rhythm; =250pg/mL if AF.
•6. =14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 982
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 982

•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

发起方

Department of Cardiology, Hartcentrum, University Medical Center Groningen