Effect of Spironolactone on Exercise Capacity in functionally impaired older people without heart failure: a double blind placebo controlled trial - Spironolactone and exercise capacity in older people
- Conditions
- Older people with impairment in activities of daily living (sarcopenia)MedDRA version: 9.1Level: LLTClassification code 10063024Term: Sarcopenia
- Registration Number
- EUCTR2008-002373-12-GB
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
People over the age of 65 years, with self reported difficulties in activities of daily living
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A clinical diagnosis of symptomatic heart failure according to ESRC criteria
Asymptomatic left ventricular systolic dysfunction
Already taking spironolactone
On ACE inhibitor or angiotensin receptor blocker
Systolic BP <100mmHg
Serum potassium >5.0 mmol/l
Serum sodium <130mmol/l
Creatinine >200 umol/l
eGFR <30ml
Addison’s disease
Previous reported intolerance of spironolactone
Cognitive impairment precluding informed consent
Wheelchair bound
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method