Condition category
Circulatory System
Date applied
21/02/2006
Date assigned
29/03/2006
Last edited
02/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nimit Shah

ORCID ID

Contact details

Department of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sha001

Study information

Scientific title

Acronym

Study hypothesis

Aldosterone blockade improves endothelial function in patients with coronary artery disease without heart failure

Ethics approval

Approved by the Regional Research Ethics Committee on 09/07/2004, reference number: 04/S1401/82

Study design

Randomised, double-blind, placebo-controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coronary artery disease

Intervention

Spironolactone versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Spironolactone

Primary outcome measures

Improvement in endothelial function

Secondary outcome measures

1. Changes in brain natriuretic peptide (BNP)
2. Amino-terminal propeptide of type III procollagen (PIIINP)
3. Angiotensin converting enzyme (ACE) activity
4. Heart rate variability
5. QT dispersion

Overall trial start date

05/01/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient with known coronary artery disease
2. Chronic stable angina

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88

Participant exclusion criteria

1. Left ventricular systolic dysfunction
2. Renal failure
3. Hyperkalaemia
4. Warfarin therapy

Recruitment start date

05/01/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Department of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Hearth Foundation

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

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17921831

Publication citations

  1. Results

    Shah NC, Pringle SD, Donnan PT, Struthers AD, Spironolactone has antiarrhythmic activity in ischaemic cardiac patients without cardiac failure., J. Hypertens., 2007, 25, 11, 2345-2351, doi: 10.1097/HJH.0b013e3282e9a72d.

Additional files

Editorial Notes