Condition category
Not Applicable
Date applied
07/08/2008
Date assigned
21/08/2008
Last edited
29/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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 on 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

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

01/10/2008

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Ageing & Health
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 of the Scottish Executive Health Department (UK) (ref: CZB/4/635)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

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