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Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Reduce salt intake
Sponsored by
St George's, University of London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Blood pressure, Sodium, Dietary, Hypertension or prehypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. George's University of London,

Outcomes

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.

Full Information

First Posted
September 8, 2005
Last Updated
June 8, 2015
Sponsor
St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00152074
Brief Title
Salt Reduction on Blood Pressure and Cardiovascular Organ Damage
Official Title
Effects of Modest Salt Reduction on Blood Pressure and Markers of Target Organ Damage in Patients With Untreated Essential Hypertension or Prehypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St George's, University of London

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure, Sodium, Dietary, Hypertension or prehypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Reduce salt intake
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham A MacGregor, MD
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. George's University of London,
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32475312
Citation
Chen L, He FJ, Dong Y, Huang Y, Wang C, Harshfield GA, Zhu H. Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids in Untreated Hypertensives: A Randomized, Double-Blind, Placebo-Controlled Trial. Hypertension. 2020 Jul;76(1):73-79. doi: 10.1161/HYPERTENSIONAHA.120.14800. Epub 2020 Jun 1.
Results Reference
derived
PubMed Identifier
31079530
Citation
Chen L, He FJ, Dong Y, Huang Y, Harshfield GA, Zhu H. Sodium Reduction, Metabolomic Profiling, and Cardiovascular Disease Risk in Untreated Black Hypertensives. Hypertension. 2019 Jul;74(1):194-200. doi: 10.1161/HYPERTENSIONAHA.119.12880. Epub 2019 May 13.
Results Reference
derived

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Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

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