Condition category
Not Applicable
Date applied
07/08/2008
Date assigned
21/08/2008
Last edited
01/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marion McMurdo

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2008-002373-12

ClinicalTrials.gov number

Protocol/serial number

CZB/4/635

Study information

Scientific title

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

Acronym

Study hypothesis

Inhibition of the renin angiotensin aldosterone system with spironolactone will improve exercise capacity in older people without heart failure.

Ethics approval

Tayside Committee of Medical Research Ethics, 06/08/2008, ref: 08/S1402/34

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Decline in physical function with age

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Spironolactone

Primary outcome measures

Change in six minute walking distance over 20 weeks from baseline

Secondary outcome measures

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)

Overall trial start date

01/10/2008

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/11/2008

Recruitment end date

01/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office (ref: CZB/4/635)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol is available from the authors on request but is not available online.

IPD sharing statement
Study 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

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23706520

Publication citations

  1. Results

    Burton LA, Sumukadas D, Witham MD, Struthers AD, McMurdo ME, Effect of spironolactone on physical performance in older people with self-reported physical disability., Am. J. Med., 2013, 126, 7, 590-597, doi: 10.1016/j.amjmed.2012.11.032.

Additional files

Editorial Notes

01/11/2017: Plain English summary added. 24/10/2017: Recruitment dates and IPD sharing statement added.