Salt Study: Inhibited Breathing Pattern and Sodium Inhibitors in Sodium Sensitivity of Blood Pressure

Completed

Conditions studied: Hypertension

In brief

The purpose of this study is to test the hypothesis that blood pressure sensitivity to high sodium intake in healthy humans is characterized by increased urinary excretion of two endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC). The study also tests the hypothesis that women who breathe slowly and have high resting end tidal CO2 at rest are more likely to have low plasma renin activity and sodium sensitivity of blood pressure than those who breathe more rapidly and maintain lower end tidal CO2.

Key facts

Study ID

NCT00800228

Run by

National Institute on Aging (NIA)

People needed

96

Starts

2003-03-01

Expected to finish

2006-12-01

Last updated by the study team

2008-12-02

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 40-70
• Caucasian
• Nonsmoking
• Free of respiratory, cardiac, liver and kidney disease, and diabetes
• Resting systolic blood pressure less than or equal to 139 mmHg AND resting diastolic blood pressure of less than or equal to 89 mmHg15
• BMI less than or equal to 30
• Negative pregnancy test for female participants whose last menstrual period was less than one year prior to study enrollment
• For Group 1, willing to provide 24-hr urine samples for 12 consecutive days
• For Group 2, women on combination oral contraceptives (those containing estrogen and progesterone) will be eligible for the study, with equal numbers in the "fast" and "slow" breathing groups
• For Group 2, in premenopausal women, regular menstrual cycles for at least 6 months prior to study entry

You may not qualify if…

• Presence of respiratory, cardiac, liver or kidney disease; diabetes, or hypertension
• Use of medications which can affect respiratory rate, such as major tranquilizers, narcotics, or benzodiazepines
• Diuretic or steroid use
• Cigarette smoking within the past 12 months
• BMI > 30 kg/m2
• Postmenopausal women on hormone replacement therapy
• Pregnancy or lactation in the last 12 months
• In premenopausal women, irregular menstrual cycles in the 6 months prior to study entry
• For Group 2, respiratory rate in the middle third of the distribution of breathing frequency in BLSA
• For Group 2, pre-menopausal women not taking oral contraceptives who are in the follicular phase of the menstrual cycle

Where it is running

• NIA Clinical Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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