Preventing Falls with ACE inhibitor tablets

Phase 1

Conditions: Falls in older people
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-001677-24-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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

• 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; eGFR<30ml/hr; serum creatinine >170umol/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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>End - 15 weeks

Secondary Outcome Measures