Preventing Falls with ACE inhibitor tablets

Do ACE inhibitors reduce postural instability in older people?: Towards a novel approach to falls prevention. - The PREFACE Study: Preventing Falls with ACE inhibitors

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001677-24-GB

Enrollment

Registered

2013-05-24

Start date

2013-06-20

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Falls in older people

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: • Aged 65 years or over • One or more self-reported falls in previous 12 months • Able to provide informed consent 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 80

Exclusion criteria

Exclusion criteria: • Already taking ACE inhibitor or Angiotensin Renal Blocker (ARB); • Contraindication to ACE inhibitor use (previous intolerance; significant aortic outflow obstruction [peak gradient >30mmHg]; serum potassium >5.0mmol/l; eGFR170umol/l) • Patients who have stopped ACEi or ARB after specialist falls assessment in the last 6 months; • Clinical diagnosis of heart failure or asymptomatic left ventricular systolic dysfunction • systolic BP>160mmHg or <100mmHg at screening visit;. • wheelchair bound • clinical diagnosis of Parkinson’s • Current use of NSAIDs • Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded • Intolerance to lactose • cognitive impairment precluding informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective will be to examine the effect of perindopril compared with placebo on the change in standing balance over a 15 week period;Secondary Objective: To examine the effects of perindopril as compared to placebo on balance whilst moving, leg muscle strength, rate of falls, muscle endurance and muscle tiredness. ;Primary end point(s): Postural sway will be assessed using a force plate. Change in Anterio-posterior (AP) sway between perindopril and placebo groups as measured at baseline and end of 15 weeks treatment. ;Timepoint(s) of evaluation of this end point: Baseline - 0 weeks End - 15 weeks	—

Measure

Time frame

Main Objective: The primary objective will be to examine the effect of perindopril compared with placebo on the change in standing balance over a 15 week period;Secondary Objective: To examine the effects of perindopril as compared to placebo on balance whilst moving, leg muscle strength, rate of falls, muscle endurance and muscle tiredness. ;Primary end point(s): Postural sway will be assessed using a force plate. Change in Anterio-posterior (AP) sway between perindopril and placebo groups as measured at baseline and end of 15 weeks treatment. ;Timepoint(s) of evaluation of this end point: Baseline - 0 weeks End - 15 weeks

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Secondary

Measure	Time frame
Secondary end point(s): •Static postural stability measures: Change in Mediolateral sway, average sway velocity and total sway area after 15 weeks of treatment •Dynamic postural stability: Change in Limits of Stability (LOS) after 15 weeks of treatment with perindopril compared to placebo •Quadriceps strength: Change in sometric quadriceps maximum voluntary contraction strength (QMVC) after 15 weeks of treatment with perindopril compared to placebo •Falls : Difference in falls rates, between the perindopril and placebo groups. This study is not powered to determine this accurately but such information will provide important safety information as well as providing preliminary data for powering a future study. • Magnetic femoral nerve stimulation (subset of participants who consent, only): Change in the greatest twitch tension generated in the quadriceps (TwQ) using magnetic femoral nerve stimulation after 15 weeks of treatment with perindopril compared to placebo. Iimprovement in Endurance and fatigue using repeated QMVC after 15 weeks of treatment with perindopril compared to placebo. ;Timepoint(s) of evaluation of this end point: Baseline - 0 weeks End - 15 weeks	—

Measure

Time frame

Secondary end point(s): •Static postural stability measures: Change in Mediolateral sway, average sway velocity and total sway area after 15 weeks of treatment •Dynamic postural stability: Change in Limits of Stability (LOS) after 15 weeks of treatment with perindopril compared to placebo •Quadriceps strength: Change in sometric quadriceps maximum voluntary contraction strength (QMVC) after 15 weeks of treatment with perindopril compared to placebo •Falls : Difference in falls rates, between the perindopril and placebo groups. This study is not powered to determine this accurately but such information will provide important safety information as well as providing preliminary data for powering a future study. • Magnetic femoral nerve stimulation (subset of participants who consent, only): Change in the greatest twitch tension generated in the quadriceps (TwQ) using magnetic femoral nerve stimulation after 15 weeks of treatment with perindopril compared to placebo. Iimprovement in Endurance and fatigue using repeated QMVC after 15 weeks of treatment with perindopril compared to placebo. ;Timepoint(s) of evaluation of this end point: Baseline - 0 weeks End - 15 weeks

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Countries

United Kingdom

Contacts

Public ContactDr Deepa Sumukadas

University of Dundee

d.sumukadas@dundee.ac.uk01382 383086

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026