Contemporary Heart Failure Management : A Randomised, Placebo-Controlled Trial to Measure the Effects of Low Dose Digoxin on Haemodynamics and Symptoms in Patients with Heart Failure - Contemporary Heart Failure Management : The Added Role of Digoxin

Hull and East Yorkshire Hospitals NHS Trust0 个研究点目标入组 0 人开始时间: 2010年8月25日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1. Left ventricular ejection fraction = 45% measured by echocardiography.
•2. NTproBNP >100 pmol/L
•3. NYHA functional class II-IV.
•4. Treated with beta blocking agents.
•5. Clinically stable on maximally tolerated heart failure therapeutics for = 3 months.
•6. All patients must be in sinus rhythm.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Currently prescribed digoxin or discontinued previously due to intolerance.
•2. Allergy to Ascorbic acid or lactose.
•3. Estimated Glomerular Filtration Rate <30mls/min.
•4. Resting heart rate < 60/min.
•5. 2nd or 3rd degree heart block, sinus node disorder or known accessory pathway
•or any other listed contraindications to digoxin in the British National Formulary
•6. Plasma potassium level < 3.5mmol/dl or >5.5 mmol/dl.
•7. Plasma magnesium level < 0.6 mmol/dl.
•8. Pregnant or breastfeeding.
•9. Allergy to adhesive pads.
•10. Age <18 or > 90 years old.
•11. History of hypertrophic/constrictive or restrictive cardiomyopathy.
•12. Permanently ventricular paced.
•13. Mechanical valve replacement.
•14. MI or stroke in the preceding 3 months.
•15. Haemodynamically significant valvular disease.
•16. Enrolled in trials involving other medicinal products.
•17. Any patient planning to undergo a surgical or interventional procedure which
•falls within the study period.

发起方

Hull and East Yorkshire Hospitals NHS Trust