SALT STUDY: Effect of varying sodium intake and activity on plasma concentrations of N-Terminal BNP in normal subjects and patients with prior Q-wave myocardial infarction (MI)
| ISRCTN | ISRCTN88264942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88264942 |
| Protocol serial number | N0084160159 |
| Sponsor | Department of Health |
| Funders | The North and South Bank Research and Development Consortium (UK), NHS R&D Support Funding (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/07/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J G F Cleland
Scientific
Scientific
Academic Cardiology Department
Cardiology
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 624083 |
|---|---|
| J.G.Cleland@hull.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SALT STUDY |
| Study objectives | To determine the effects of altering dietary sodium intake or daily physical activity on plasma concentrations of N-Terminal BNP in normal subjects and patients who have had a prior Q-wave MI. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sodium intake |
| Intervention | The results of this trial will be used to inform clinical decision making based on NT_BNP results. Other areas involved: Cardiology, Nuclear Medicine Department. The study is an open-label, randomised trial comparing the effects of varying dietary sodium and level of daily activity in 30 normal subjects patients recruited from General Practice and 30 patients with prior Q-wave myocardial infraction at the Nuclear Medicine Department at Hull Royal Infirmary. |
| Intervention type | Other |
| Primary outcome measure(s) |
Brain Natriuretic Peptides (BNP) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 09/04/2007 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. 30 normal subjects over 60 years old 2. 30 mobile patients over 60 years old who have had a Q-wave MI and left ventricular ejection fraction (LVEF) less than 45% Resources/Patient: 1. Electrocardiogram (ECG) 2. Echocardiography 3. Treadmill exercise with VO2 measurement for each patient |
| Key exclusion criteria | 1. No angina 2. No heart failure 3. Not receiving diuretics 4. No renal impairment |
| Date of first enrolment | 09/02/2005 |
| Date of final enrolment | 09/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Cardiology Department
Hull
HU16 5JQ
United Kingdom
HU16 5JQ
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 |
