ß3 adrenergic agoniSt treatment in chronic Pulmonary HypERtEnsion secondary to heart failure: a randomized placebo-controlled phase 2 clinical trial

Fundació Clínic per la recerca Biomédica0 个研究点目标入组 80 人开始时间: 2016年11月17日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Written inform consent;
•=18 years-old;
•HF with reduced, intermediate or preserved ejection fraction, according to the definition of the European Society of Heart Failure guidelines.
•Significant PH combined postcapillary and precapillary PH determined by RHC showing the following:
•Pulmonary artery wedge pressure or enddiastolic LV pressure =15 mmHg;
•- Mean PAP=25 mmHg and:
•.PVR=3 UW and/or diastolic gradient=7 mmHg or transpulmonary gradient=12mmHg.
•NYHA functional class II-III;
•On optimized evidence-based pharmacological treatment;
•Stable clinical condition defined as no changes in therapeutic regimen or hospitalization in the 30 days preceding recruitment and no current plan for changing therapy.
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Non-coronary cardiac surgery within the 12 months preceding recruitment performed or scheduled;
•Myocardial infarction or coronary revascularization in the last 3 months.
•Resynchronization therapy implanted in the last 6 months.
•Sinusal tachycardia or uncontrolled atrial fibrillation (HR>100 bpm);
•Uncontrolled systemic hypertension or symptomatic hypotension.
•Infiltrative cardiomyopathy.
•Premenopausal women with childbearing potential.
•Expected survival <1 year due to a disease other than HF;
•Severe renal failure (GFR <30 mL/min/1.73 m2 or hemodialysis);
•Severe hepatic impairment (transaminases >3 upper limit of normality);
•cQT interval on the ECG >430 ms in male or >450 ms in female;
•Concomitant use of specific pulmonary vasodilators (sildenafil, bosentan, macitentan, riociguat and other endothelin receptor antagonists, fosfodiestarase-5 inhibitors or guanilate cyclase agonists.
•Under treatment with digoxin, flecainide, propafenone, dabigatran, tricyclic antidepressants, and other CYP2D6 inhibitors (other than betablockers).
•Severe COPD.
•Severe restrictive pulmonary disease.
•Participation in another clinical trial.
•Allergy to mirabegron or excipients.

发起方

Fundació Clínic per la recerca Biomédica