Does aldosterone blockade improve endothelial dysfunction in patients with coronary artery disease but without heart failure?
| ISRCTN | ISRCTN70010120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70010120 |
| Secondary identifying numbers | Sha001 |
- Submission date
- 21/02/2006
- Registration date
- 29/03/2006
- Last edited
- 02/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nimit Shah
Scientific
Scientific
Department of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised, double-blind, placebo-controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Aldosterone blockade improves endothelial function in patients with coronary artery disease without heart failure |
| Ethics approval(s) | Approved by the Regional Research Ethics Committee on 09/07/2004, reference number: 04/S1401/82 |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Spironolactone versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Spironolactone |
| Primary outcome measure | 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 study start date | 05/01/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 88 |
| Key inclusion criteria | 1. Patient with known coronary artery disease 2. Chronic stable angina |
| Key exclusion criteria | 1. Left ventricular systolic dysfunction 2. Renal failure 3. Hyperkalaemia 4. Warfarin therapy |
| Date of first enrolment | 05/01/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
Department of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
Scotland
United Kingdom
"ROR" |
https://ror.org/03h2bxq36 |
|---|
Funders
Funder type
Charity
British Hearth Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2007 | Yes | No |
