Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J G F Cleland

ORCID ID

Contact details

Academic Cardiology Department
Cardiology
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom
+44 (0)1482 624083
J.G.Cleland@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084160159

Study information

Scientific title

Acronym

SALT STUDY

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Brain Natriuretic Peptides (BNP)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

09/02/2005

Overall trial end date

09/04/2007

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. No angina
2. No heart failure
3. Not receiving diuretics
4. No renal impairment

Recruitment start date

09/02/2005

Recruitment end date

09/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Cardiology Department
Hull
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

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

Publication citations

Additional files

Editorial Notes