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Spironolactone and exercise capacity in older people

Effect of spironolactone on exercise capacity in older people without heart failure: a double-blind placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03869290
Enrollment
120
Registered
2008-08-21
Start date
2008-11-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Decline in physical function with age Not Applicable Physical function

Interventions

Spironolactone 25 mg once daily or placebo once daily for a period of 20 weeks.

Sponsors

University of Dundee (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 65 years and over, either sex 2. Self-reported problems with activities of daily living

Exclusion criteria

Exclusion criteria: 1. A clinical diagnosis of symptomatic heart failure according to the Economic and Social Research Council (ESRC) criteria 2. Asymptomatic left ventricular systolic dysfunction 3. Already taking spironolactone 4. On angiotensin converting enzyme inhibitor or angiotensin receptor blocker 5. Systolic blood pressure less than 100 mmHg 6. Serum potassium greater than 5.0 mmol/l 7. Serum sodium less than 130 mmol/l 8. Creatinine greater than 200 umol/l 9. Estimated glomerular filtration rate (eGFR) less than 30 ml 10. Addison's disease 11. Previous reported intolerance of spironolactone 12. Cognitive impairment precluding informed consent 13. Wheelchair bound 14. Unwilling to participate

Design outcomes

Primary

MeasureTime frame
Change in six minute walking distance over 20 weeks from baseline

Secondary

MeasureTime frame
Change in the following from baseline to 20 weeks: 1. Time taken to perform the timed get up and go test 2. EuroQol 5D (-0.59 to 1.0) and Visual Analogue Scale (0 - 100) 3. Functional Limitation Profile Scale 4. Hospital Anxiety and Depression Scale (anxiety 0 - 21; depression 0 - 21) 5. Incremental shuttle walk test (time and distance)

Countries

United Kingdom

Outcome results

None listed

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