Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

Hypertension Clinical Trial

Official title:

Effects of Modest Salt Reduction on Blood Pressure and Markers of Target Organ Damage in Patients With Untreated Essential Hypertension or Prehypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152074
• Other study ID #: CH/der/03.0214
• Secondary ID: N02034
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: June 8, 2015
• Start date: April 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2006
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

Behavioral:
• Reduce salt intake

Locations

Country	Name	City	State
United Kingdom	St. George's University of London,	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.