ISRCTN90094835已完成4 期
Perindopril and leucine to improve muscle function in older people (LACE study)
HS Tayside0 个研究点目标入组 145 人开始时间: 2015年2月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29301558 protocol 2022 Results article in https://doi.org/10.3310/LLBX6901 (added 10/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 70 and over
- •2. Sarcopenia criteria according to EWGSOP definition, based on:
- •2.1. Low total skeletal muscle mass on BioImpedance Assay (BIA) using the BIA 101 device (<13Kg for women, <20.5Kg for men)
- •2.2. Either low gait speed (<0.8 m/s on 4m walk) or low handgrip strength (<20Kg for women, <30Kg for men)
排除标准
- •1. Contraindications or existing indications to therapies or placebo
- •1.1. Known clinical diagnosis of chronic heart failure (by European Society of Cardiology criteria)
- •1.2. Confirmed LV systolic dysfunction on any imaging modality
- •1.3. Known aortic stenosis (peak gradient >30mmHg)
- •1.4. Systolic BP<90 mmHg (supine)
- •1.5. Dizziness on standing associated with a postural drop of >20/10mmHg (asymptomatic orthostatic hypotension will not be a contraindication)
- •1.6. Serum Creatinine >180 umol/L or eGFR<30ml/min by MDRD4 calculation
- •1.7. K>5.0 mmol/L; Na<130 mmol/L
- •1.8. Using ACEi, Angiotensin receptor blocker, aldosterone blocker or leucine already
- •1.9. Previous adverse reaction to ACEi or leucine
- •1.10. Current use of oral NSAIDs (aspirin is permitted, as are topical NSAIDs)
- •1.11. Lactose intolerance
- •2. Contraindications to consent or undertaking study outcomes
- •2.1. Peripheral oedema present above knee level
- •Unable to mobilise without human assistance (walking aids allowed)
- •2.2. Unable to give written informed consent
- •2.3. Currently enrolled in another research study, or less than 30 days since completing another research study
- •3. Overlap with other myopathic conditions or important confounders
- •3.1. Currently enrolled in a time-limited exercise-based rehabilitation programme
- •3.2. Any progressive neurological or malignant condition with life expectancy <6 months
- •3.3. Severe COPD (GOLD stage IV)
- •3.4. Known myositis
- •3.5. Self-reported weight loss of >10% in last 6 months (to exclude significant cachexia)
- •3.6. Known uncontrolled thyrotoxicosis
- •3.7. 7.5mg/day or greater prednisolone use (or equivalent)
研究者
相似试验
进行中（未招募）
1 期
Perindopril and Leucine to improve muscle function in older peopleEUCTR2014-003455-61-GBTayside Academic Sciences Centre440
已完成
3 期
L-Citrulline in Patients With Post-Polio SyndromePost-Polio SyndromeNCT02801071Dirk Fischer30
已完成
不适用
Preserving Muscle Mass and Function in Bedridden Older AdultsBed RestNCT01846130The University of Texas Medical Branch, Galveston123
已完成
不适用
Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and ObesityObesity Associated DisorderNCT06001632University of Glasgow50
已完成
1 期
Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and MetforminDuchenne Muscular DystrophyNCT02516085University Hospital, Basel, Switzerland5