Perindopril and Leucine to improve muscle function in older people - Leucine and ACEi to treat sarcopenia

Tayside Academic Sciences Centre0 个研究点目标入组 440 人开始时间: 2015年3月10日最近更新: 2020年4月6日

试验速览

暂无简介。

•Age 70 and over
•Sarcopenia criteria according to European Working Group definition, based on:
•- low total skeletal muscle mass on BioImpedance Assay (BIA) using the BIA 101 device (<13Kg for women, <20.5Kg for men).
•- and either low gait speed (<0.8 m/s on 4m walk) or low handgrip strength (<20Kg for women, <30Kg for men)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 440

•a)Contraindications or existing indications to therapies or placebo
•-Known clinical diagnosis of chronic heart failure (by European Society of Cardiology criteria)
•-Confirmed LV systolic dysfunction on any imaging modality
•-Known aortic stenosis (peak gradient >30mmHg)
•-Systolic BP<90 mmHg (supine)
•-Dizziness on standing associated with a postural drop of >20/10mmHg (asymptomatic orthostatic hypotension will not be a contraindication)
•-Serum Creatinine >180 umol/L or eGFR<30ml/min by MDRD4 calculation
•-K>5.0 mmol/L; Na<130 mmol/L
•-Using ACEi, Angiotensin receptor blocker, aldosterone blocker or leucine already
•-Previous adverse reaction to ACEi or leucine
•-Current use of NSAIDs
•-Lactose intolerance
•b)Contraindications to consent or undertaking study outcomes
•-Unable to mobilise without human assistance (walking aids allowed)
•-Unable to give written informed consent
•c)Overlap with other myopathic conditions or important confounders
•-Currently enrolled in an exercise training programme
•-Any progressive neurological or malignant condition with life expectancy <6 months
•-Severe COPD (GOLD stage IV)
•-Known myositis
•-Self-reported weight loss of >10% in last 6 months (to exclude significant cachexia)
•-Known uncontrolled thyrotoxicosis
•->7.5mg/day prednisolone use (or equivalent)

发起方

Tayside Academic Sciences Centre