Salt Reduction on Blood Pressure and Cardiovascular Organ... | NCT00152074

Studies
Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

NCT00152074

Sponsor

St George's, University of London

Status

Completed

Last Update Posted

Jun 9, 2015Estimated

Enrollment

210Estimated

Phase

Phase 3

Conditions

Hypertension

Interventions

Reduce salt intake

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
N02034

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 9, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2015

Last Update Posted Date

Jun 9, 2015Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Name	Type	Description	Arm Group Labels	Other Names
Reduce salt intake	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Graham A MacGregor, MD	St George's, University of London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. George's University of London,		London		SW17 0RE	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32475312	Derived	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.
31079530	Derived

ID	Term
D006973	Hypertension
D058246	Prehypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases