Nocturnal Hypertension and Non-Dipping Blood Pressure

Not Applicable

Completed

• Conditions: Hypertension; Obstructive Sleep Apnea
• Interventions: Dietary Supplement: Dietary sodium

• Registration Number: NCT03128177
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to determine if high salt diet contributes to high nighttime blood pressure. The investigators will determine if high compared to low salt diet increases 24-hour blood pressure levels. The investigators will also determine if high salt diet affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also determine how high salt diet affects the activity of certain genes related to control of blood pressure. A total of 60 participants will be enrolled in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Nocturnal hypertension

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Exclusion Criteria

• Stage 2 clinic hypertension
• History of congestive heart failure
• Chronic kidney disease,
• Diabetes with insulin use
• History of a cardiovascular event
• Pregnant or nursing
• Current use of continuous positive airway pressure
• Shift work
• A known circadian rhythm disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High sodium diet	Dietary sodium	High sodium diet is 6 g sodium per day for 10 days
Low sodium diet	Dietary sodium	Low sodium diet is 1.5 g sodium per day for 10 days

Primary Outcome Measures

Name	Time	Method
24-hour blood pressure	Baseline to 7 days after start of dietary period	Blood pressure measured by an ambulatory blood pressure monitor

Secondary Outcome Measures

Name	Time	Method
Obstructive sleep apnea	Baseline to 7 days after start of dietary period	Severity of obstructive sleep apnea as determine by the apnea hypopnea index

Trial Locations

Locations (1)

David A. Calhoun, MD; 🇺🇸 Birmingham, Alabama, United States