Beta 3 agonist treatment in heart failure (BEAT-HF II) - BEAT-HF II

Hjertemedicinsk klinik, Rigshospitalet0 个研究点目标入组 70 人开始时间: 2016年6月16日最近更新: 2021年5月25日

适应症

试验速览

暂无简介。

•1.Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
•2.Left ventricular ejection fraction (LVEF) < 35% as assessed by cardiac CT
•3.Stable sinus rhythm (SR)
•4.On optimised evidence-based pharmacological HF treatment stable > 4 weeks with no current plan for changing HF therapy. The therapy must include a beta-blocker.
•5.No change in diuretics <4 weeks
•6.>18 years
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1.Acute myocardial infarction (AMI) or revascularisation < 3 month ago
•2.Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
•3.Uncorrected significant primary obstructive valve disease
•4.Planned major surgery including cardiac revascularisation
•5.Hemodynamically significant obstructive cardiomyopathy
•6.Acute myocarditis or constrictive pericarditis
•7.Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 40 ml/min/1,73 m2) diseases
•8.Heart failure due to uncorrected thyroid disease
•9.Cardiac mechanical support
•10.< 6 months after CRT
•11.Uncontrolled hypotension (defined as symptomatic systolic blood pressure < 90 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
•12.Unable to give informed consent
•13.Reduced compliance
•14.All women of child bearing potential will be required to use adequate contraception
•15.Pregnant or lactating women
•16.Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin (only applies to Study A).
•For exclusion from the CT part of the study
•-Known allergy to iodine containing contrast
•-Estimated GFR < 40 ml/min/1.73 m2

发起方

Hjertemedicinsk klinik, Rigshospitalet