A multi-centre randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on the progression of left ventricular mass and diastolic function in patients with structural heart disease. - BETA3_LVH

niversité catholique de Louvain (UCL)0 个研究点目标入组 296 人开始时间: 2016年3月1日最近更新: 2022年3月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 296

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Age between 18 and 90 years
••Morphological signs of structural cardiac remodelling by echocardiography, i.e. increased LV mass index (=95 g/m2 or higher for female; =115 g/m2 or higher for male subjects (Ponikowski et al. 2016)) or end-diastolic wall thickness >= 13 mm in at least one wall segment
•Written informed consent
•For subjects unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the subject has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the subject.
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 176

排除标准

•Unstable arterial hypertension with systolic BP=160 mm Hg and/or diastolic BP=100 mm Hg (confirmed at three consecutive office measurements in sitting position); if so, the patient may be re-screened after optimization of anti-hypertensive treatment
•Hypertensive patients not under stable therapy according to current guideline algorithm (Mancia et al. 2013) (including stable medication for at least 4 weeks before inclusion)
•Documented ischemic cardiac disease:
•ocurrent angina pectoris or
•oischemia on stress test or
•ountreated coronary stenosis >50% or
•ohistory of acute myocardial infarction (AMI) or
•ocoronary artery bypass graft (CABG, < than 3 months prior to screening) or
•opercutaneous transluminal coronary angioplasty (PTCA) less than 3 months prior to screening.
•Patients with uncontrolled recurrent persistent and permanent atrial fibrillation (AF) according to AHA/ACC/ESC guidelines (Dixon et al. 2005) (with a heart rate > 100/min, RACE II - (Groenveld et al. 2013, 2013)). If AF with HR>100/min, the patient may be rescreened after treatment for rate control.
•History of hospitalization for overt heart failure within last 12 months
•History of high degree impulse conduction blocks (> 2nd degree AV block type 2)
•Patients after heart transplantation
•Genetic hypertrophic or dilated cardiomyopathy
•Dysthyroidism
•Severe valvulopathy (less than 1 cm2 aortic valve area, mitral insufficiency of severe grade at Doppler echo)
•Congenital valvulopathies
•Patients with a known history of QT prolongation (QT>450ms) (CHMP/ICH, 2005) or patients with documented QT prolongation (QT>450 ms) while taking medicinal products known to prolong the QT interval.
•NYHA-class > II
•BMI > 40 kg/m2
•EF < 50%, regardless of symptoms
•Known other cause (i.e. COPD) of respiratory dysfunction; patients under positive pressure (CPAP) treatment for sleep apnea syndrome may be included, provided they have been efficiently controlled by CPAP for at least one year before inclusion in the study
•Moderate renal impairment defined as eGFR < 30 ml/min
•Abnormal liver function tests (AST or ALT >2 X upper normal limit or patients with known hepatic impairment defined as Child-Pugh class B or higher)
•Type I diabetes, complicated type II diabetes (i.e. with documented coronary macroangiopathy , cfr exclusion criterion 1 or documented other vascular complication) (National Diabetes Education Initiative - NDEI).
•Patients with anaemia (male: Hb <130 g/l, female: Hb <120 g/l)
•Patients with bladder outlet obstruction
•Patients using antimuscarinic cholinergic drugs for treatment of OAB
•Current use of digitalis, bupranolol, propranolol, nebivolol (known to interfere with ß3AR signalling)
•Note: patients are allowed to take a ß(1-2)-blocker, other than the drugs listed above (for explanation, see chapter 5.4.5).
•Patients continuously treated with Sildenafil or other PDE5 inhibitors.
•Current use of antifungal azole derivatives (fluconazole, itraconazole, miconazole, posaconazole, voriconazole) (known inhibitors of CYP3A4, the main metabolizer of mirabegron)
•Current treatment with mirabegron or indication for future treatment with mirabegron due to other indications
•Contraindication for MRI (e.g. defibrillator, ferromagnetic devices or severe claustrophobia, , pacemaker - the latter only, if MRI is contraindicated)
•Pregnant or nursing women
•Women of child bearing potential

研究者

发起方

niversité catholique de Louvain (UCL)

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