Nocturnal Hypertension and Non-Dipping Blood Pressure

Hypertension Clinical Trial

Official title:

Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128177
• Other study ID #: F150508004
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Dietary Supplement:
• Dietary sodium
High (6 g) versus low (1.5 g) sodium diet

Locations

Country	Name	City	State
United States	David A. Calhoun, MD	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour blood pressure	Blood pressure measured by an ambulatory blood pressure monitor	Baseline to 7 days after start of dietary period
Secondary	Obstructive sleep apnea	Severity of obstructive sleep apnea as determine by the apnea hypopnea index	Baseline to 7 days after start of dietary period