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Completed

NCT Number: NCT03128177

Nocturnal Hypertension and Non-Dipping Blood Pressure

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.

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Key information

Conditions

Hypertension Apnea Cardiovascular Diseases Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

48 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

David A. Calhoun, MD

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nocturnal hypertension

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

Treatment and study plan

Dietary sodium

Dietary Supplement

High (6 g) versus low (1.5 g) sodium diet

Primary outcomes

  1. 24-hour blood pressure

    Time frame: Baseline to 7 days after start of dietary period

    Blood pressure measured by an ambulatory blood pressure monitor

Secondary outcomes

  1. Obstructive sleep apnea

    Time frame: Baseline to 7 days after start of dietary period

    Severity of obstructive sleep apnea as determine by the apnea hypopnea index

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2017
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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