Perindopril and Leucine to improve muscle function in older people

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003455-61-GB

Enrollment

440

Registered

2015-03-10

Start date

2015-02-11

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia MedDRA version: 17.1 Level: PT Classification code 10063024 Term: Sarcopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Perindopril Product Name: Perindopril 2mg Product Code: Perindopril 2mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: Perindopril CAS Number: 107133-36-8 Current Sponsor code: Pe

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) yes F.1.3.1 Number of subjects for this age range 440

Exclusion criteria

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 BP20/10mmHg (asymptomatic orthostatic hypotension will not be a contraindication) -Serum Creatinine >180 umol/L or eGFR5.0 mmol/L; Na10% in last 6 months (to exclude significant cachexia) -Known uncontrolled thyrotoxicosis ->7.5mg/day prednisolone use (or equivalent)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of leucine and ACEi in improving physical function in older people with sarcopenia;Secondary Objective: To evaluate the effect of leucine and ACE inhibition on muscle mass in older people To evaluate biomarkers that can predict response to leucine and ACE inhibition therapies in patients with sarcopenia ;Primary end point(s): Between group difference in Short Physical Performance Battery (SPPB) score at 12 months;Timepoint(s) of evaluation of this end point: 0, 6 and 12 months	—

Measure

Time frame

Main Objective: To determine the efficacy of leucine and ACEi in improving physical function in older people with sarcopenia;Secondary Objective: To evaluate the effect of leucine and ACE inhibition on muscle mass in older people To evaluate biomarkers that can predict response to leucine and ACE inhibition therapies in patients with sarcopenia ;Primary end point(s): Between group difference in Short Physical Performance Battery (SPPB) score at 12 months;Timepoint(s) of evaluation of this end point: 0, 6 and 12 months

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Secondary

Measure	Time frame
Secondary end point(s): Between group differences in: - Appendicular muscle mass/height squared (measured by dual energy-X ray absorptiometry), - Grip strength - Quadriceps strength (handheld dynamometry) - 6 minute walk test - Gait speed (4m walk) - Chair stands (Sit to stand test x 5) - Activities of daily living (Nottingham extended ADL questionnaire) and quality of life (EuroQol 5D questionnaire). - HOMA IR (Homeostatic Index of insulin resistance; measured from glucose and insulin levels) ;Timepoint(s) of evaluation of this end point: 0,6 and 12 months	—

Measure

Time frame

Secondary end point(s): Between group differences in: - Appendicular muscle mass/height squared (measured by dual energy-X ray absorptiometry), - Grip strength - Quadriceps strength (handheld dynamometry) - 6 minute walk test - Gait speed (4m walk) - Chair stands (Sit to stand test x 5) - Activities of daily living (Nottingham extended ADL questionnaire) and quality of life (EuroQol 5D questionnaire). - HOMA IR (Homeostatic Index of insulin resistance; measured from glucose and insulin levels) ;Timepoint(s) of evaluation of this end point: 0,6 and 12 months

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 11, 2026