Perindopril and Leucine to improve muscle function in older people

Phase 1

• Conditions: Sarcopenia; MedDRA version: 17.1Level: PTClassification code 10063024Term: SarcopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-003455-61-GB
• Lead Sponsor: Tayside Academic Sciences Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-10
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified