Analyzing Genetic Factors Involved in Blood Pressure Changes Due to Salt and Potassium Intake (The GenSalt Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00721721
• Date of registration: 22/07/2008
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Analyzing Genetic Factors Involved in Blood Pressure Changes Due to Salt and Potassium Intake (The GenSalt Study) GenSalt
• Scientific title: Genetic Epidemiology Network of Salt Sensitivity
• Date of first enrolment: October 2003
• Target sample size: 1906
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00721721
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

China

Contacts

• Name: Jiang He, MD, PhD
• Affiliation: Tulane University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion Criteria for Primary Participants:

- Between 18 and 60 years old

- Systolic blood pressure level of 130 to 160 mm Hg and/or diastolic blood pressure
level of 85 to 100 mm Hg

- Both parents (2-generation nuclear family) or at least one parent (at least a
3-generation family) is available and willing to participate in the study

- At least one sibling meets eligibility criteria for participation

Inclusion Criteria for Sibling/Spouse/Child Participants:

- Siblings and spouses must be between 18 and 60 years old; children must be more than
16 years old

- Lives in the same village as the main study participant

Exclusion Criteria for All Participants:

- Current stage 2 hypertension (systolic blood pressure level greater than or equal to
160 mm Hg and/or diastolic blood pressure level greater than or equal to 100 mm Hg)

- Current or recent (i.e., less than 1 month before the screening visit) use of
antihypertensive medications or medications that affect blood pressure

- Secondary hypertension

- History of clinical cardiovascular disease, including heart attack, congestive heart
failure, stroke, and peripheral arterial disease

- Chronic kidney failure or urinary albumin concentration of greater than or equal to
20 mg/dL

- Current diabetes (i.e., fasting serum glucose level greater than or equal to 126
mg/dL) or use of insulin or oral hypoglycemic agents

- Peptic ulcer disease requiring treatment in the 2 years before study entry

- Liver disease requiring treatment in the 2 years before study entry

- Pregnant

- Heavy alcohol drinker (i.e., more than 14 drinks per week)

- Currently adhering to a low sodium diet



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Blood Pressure

Intervention(s)

Behavioral: High Sodium Diet

Behavioral: Low Sodium Diet

Dietary Supplement: Potassium Supplementation

Primary Outcome(s)

Blood pressure [Time Frame: Measured at Day 21]

Secondary ID(s)

1412

U01 HL072507

Source(s) of Monetary Support

Please refer to primary and secondary sponsors