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

The Heart Center, Rigshospitalet0 个研究点目标入组 85 人开始时间: 2013年5月28日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•Inclusion criteria
•1.Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
•2.Left ventricular ejection fraction (LVEF) < 40%
•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) no
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Exclusion criteria
•1.Unstable cardiac condition
•2.Acute myocardial infarction (AMI) or revascularisation < 3 month ago
•3.Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
•4.Uncorrected significant primary obstructive valve disease
•5.Planned major surgery including cardiac revascularisation
•6.Hemodynamically significant obstructive cardiomyopathy
•7.Stroke with significant neurological deficit
•8.Acute myocarditis or constrictive pericarditis
•9.Symptomatic bradycardia or > 1. degree AV-block unless the patient has a pacemaker
•10.Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 50 ml/min/1,73 m2) diseases
•11.Heart failure due to uncorrected thyroid disease
•12.Cardiac mechanical support
•13.< 6 months after CRT
•14.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)
•15.Body mass index (BMI) > 35
•16.Unable to give informed consent
•17.Reduced compliance
•18.All women of child bearing potential will be required to use adequate contraception
•19.Pregnant or lactating women
•20.Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with dig

发起方

The Heart Center, Rigshospitalet