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 |
| Protocol serial number | Sha001 |
| Sponsor | University of Dundee (UK) |
| Funder | British Hearth Foundation |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo-controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Spironolactone |
| Primary outcome measure(s) |
Improvement in endothelial function |
| Key secondary outcome measure(s) |
1. Changes in brain natriuretic peptide (BNP) |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
