Spironolactone and exercise capacity in older people

ISRCTN ISRCTN03869290
DOI https://doi.org/10.1186/ISRCTN03869290
EudraCT/CTIS number 2008-002373-12
Secondary identifying numbers CZB/4/635
Submission date
07/08/2008
Registration date
21/08/2008
Last edited
20/11/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Many older people find that they become less strong as they get older, and that this loss of strength interferes with the ability to everyday activities. Loss of strength with age also leads to falls, broken bones, and the need for more help with daily activities. Although exercise works well to improve muscle strength and function even in older people, not everyone can, or wants to, exercise. Finding medications that can improve muscle function may provide an alternative way of treating this problem. Spironolactone is a medicine used to treat heart failure and high blood pressure. There is some evidence that it might have directly beneficial effects on muscle function – separate from its effects on blood pressure or the heart. This idea has not been tested before, and the aim of this study is to test whether spironolactone increases exercise capacity in functionally impaired older people without chronic heart failure.

Who can participate?
People aged 65 and over who have problems with daily living activities

What does the study involve?
Participants are randomly allocated to take either spironolactone or placebo (dummy) capsules for 5 months. Participants visit the hospital three times over the 5 months. Each visit lasts between one and two hours. At each visit, participants perform some walking tests and complete three questionnaires about how much they are able to do and how they feel. They provide details of what medicines they are taking, their blood pressure is measured and blood samples are taken (no more than a few teaspoonfuls). At the start of the study, participants undergo an echocardiography (ultrasound) scan of their heart.

What are the possible benefits and risks of participating?
Spironolactone is a diuretic drug therefore participants may pass more urine than usual. Spironolactone has been used as a medication for 60 years and is safe. However, it can occasionally cause an upset stomach, dizziness or breast enlargement. It can also increase blood potassium levels, lower sodium levels, or interfere with kidney function in some people. Blood results are closely monitored throughout the study and if any of these problems are detected, participants are taken off the medication. These problems almost always disappear on stopping the medication. The blood tests may cause some minor discomfort. Although participants are unlikely to benefit directly by taking part, those who receive the spironolactone might improve your muscle function and exercise capacity, making them feel stronger.

Where is the study run from?
Ninewells Hospital & Medical School (UK)

When is the study starting and how long is it expected to run for?
October 2008 to April 2011

Who is funding the study?
Chief Scientist Office (UK)

Who is the main contact?
Prof. Marion McMurdo

Contact information

Prof Marion McMurdo
Scientific

Section of Ageing & Health
Division of Medicine & Therapeutics
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Study information

Study designDouble-blind randomised placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffect of spironolactone on exercise capacity in older people without heart failure: a double-blind placebo-controlled trial
Study objectivesInhibition of the renin angiotensin aldosterone system with spironolactone will improve exercise capacity in older people without heart failure.
Ethics approval(s)Tayside Committee of Medical Research Ethics, 06/08/2008, ref: 08/S1402/34
Health condition(s) or problem(s) studiedDecline in physical function with age
InterventionSpironolactone 25 mg once daily or placebo once daily for a period of 20 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Spironolactone
Primary outcome measureChange in six minute walking distance over 20 weeks from baseline
Secondary outcome measuresChange 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)
Overall study start date01/10/2008
Completion date01/04/2011

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants120
Key inclusion criteria1. Aged 65 years and over, either sex
2. Self-reported problems with activities of daily living
Key exclusion criteria1. 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
Date of first enrolment01/11/2008
Date of final enrolment01/11/2010

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
Scotland
United Kingdom

Website http://www.dundee.ac.uk/
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Government

Chief Scientist Office (ref: CZB/4/635)
Government organisation / Local government
Alternative name(s)
CSO
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe protocol is available from the authors on request but is not available online.
IPD sharing planStudy data are available on request from Dr Catrina Forde (c.forde@dundee.ac.uk) for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2013 Yes No
Basic results 24/10/2017 20/11/2017 No No

Additional files

ISRCTN03869290_BasicResults_24Oct17.pdf
Uploaded 20/11/2017

Editorial Notes

20/11/2017: The basic results of this trial have been uploaded as an additional file.
01/11/2017: Plain English summary added.
24/10/2017: Recruitment dates and IPD sharing statement added.