Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

NCT00152074 | Completed Phase 3

• 2 other identifiers: CH/der/03.0214N02034
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Blood pressure; Sodium; Dietary; Hypertension or prehypertension

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

Reduce salt intake BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St. George's University of London,

London, SW17 0RE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32475312 DERIVED

• 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.

  PMID: 31079530 DERIVED

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Graham A MacGregor, MD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: April 1, 2004
• Study Completion: December 1, 2007
• Last Updated: June 9, 2015

Record last verified: 2006-09

Locations

GB (1)