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Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by St George's, University of London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00152074
First received: September 8, 2005
Last updated: September 8, 2006
Last verified: September 2006
History of Changes
  Purpose

The purpose of this study is to determine the effect of a modest reduction in salt intake on blood pressure in white, black and Asian individuals with hypertension or prehypertension, and also to determine whether a modest reduction in salt intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease.


Condition Intervention Phase
Hypertension
 Behavioral: Reduce salt intake
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Modest Salt Reduction on Blood Pressure and Markers of Target Organ Damage in Patients With Untreated Essential Hypertension or Prehypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Blood pressure and markers of target organ damage at 6 weeks of usual salt intake vs those at 6 weeks of reduced salt intake.

Secondary Outcome Measures:
  • Comparisons among different ethnic groups in the changes in blood pressure and markers of target organ damage from week 6 of usual salt intake to week 6 of reduced salt intake.

Estimated Enrollment: 210
Study Start Date: April 2004
Estimated Study Completion Date: December 2007
Detailed Description:

The average salt intake for adults in the UK is approximately 10-12 g/day. The current recommendations are to reduce salt intake to 5-6 g/day or less. Many randomised trials have shown that this reduction in salt intake has a significant effect on blood pressure, however, most previous trials were carried out in white individuals, fewer in blacks, and none in Asians.

Increasing evidence from epidemiological studies in humans and experimental studies in animals suggest that that our current high salt intake may have other harmful effects on cardiovascular health e.g. a direct effect on stroke, left ventricular hypertrophy, progression of renal disease and proteinuria independent of and additive to salt’s effect on blood pressure. However, no well-controlled trials have studied whether a modest reduction in salt intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease.

We propose to carry out a double-blind randomised trial to study the effects of a modest reduction in salt intake, as currently recommended, on blood pressure and target organ damage assessed by the measurements of 24 hour urinary albumin excretion, left ventricular mass, left ventricular diastolic function, pulse wave velocity and capillary density, in white, black and Asian individuals with hypertension or prehypertension.

Comparisons: Usual salt intake compared to reduced salt intake.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with untreated essential hypertension or prehypertension (sitting systolic blood pressure between 120 and 170 mmHg and/or sitting diastolic blood pressure between 80 and 105 mmHg)
  • Age 18 - 75 years.

Exclusion Criteria:

  • Individuals younger than 18 or older than 75 years
  • Individuals with severe hypertension i.e. blood pressure > 170/105 mmHg
  • Individuals with any secondary cause of hypertension
  • Individuals with impaired renal function with plasma creatinine greater than 150 umol/L
  • Individuals with diabetes mellitus
  • Individuals with malignancy or liver disease
  • Individuals with ischaemic heart disease or heart failure
  • Females who are pregnant or breast feeding or on the oral contraceptive pill.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152074

Contacts
Contact: Feng J He, PhD 0044-20-8725 5375 fhe@sgul.ac.uk
Contact: Graham A MacGregor, MD 0044-20-8725 5774 gmacgregor@sgul.ac.uk

Locations
United Kingdom
St. George's University of London, Recruiting
London, United Kingdom, SW17 0RE
Contact: Feng J He, PhD     0044-20-8725 5375     fhe@sgul.ac.uk    
Contact: Graham A MacGregor, MD     0044-20-8725 5774     gmacgregor@sgul.ac.uk    
Principal Investigator: Feng J He, PhD            
Principal Investigator: Graham A MacGregor, MD            
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Graham A MacGregor, MD St George's, University of London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00152074     History of Changes
Other Study ID Numbers: CH/der/03.0214, N02034
Study First Received: September 8, 2005
Last Updated: September 8, 2006
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's, University of London:
Blood pressure
Sodium
Dietary
Hypertension or prehypertension

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013