Nocturnal Hypertension and Non-Dipping Blood Pressure
Primary Purpose
Hypertension, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary sodium
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring nocturnal hypertension, non-dipping blood pressure, obstructive sleep apnea
Eligibility Criteria
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
Sites / Locations
- David A. Calhoun, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High sodium diet
Low sodium diet
Arm Description
High sodium diet is 6 g sodium per day for 10 days
Low sodium diet is 1.5 g sodium per day for 10 days
Outcomes
Primary Outcome Measures
24-hour blood pressure
Blood pressure measured by an ambulatory blood pressure monitor
Secondary Outcome Measures
Obstructive sleep apnea
Severity of obstructive sleep apnea as determine by the apnea hypopnea index
Full Information
NCT ID
NCT03128177
First Posted
April 20, 2017
Last Updated
June 10, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT03128177
Brief Title
Nocturnal Hypertension and Non-Dipping Blood Pressure
Official Title
Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obstructive Sleep Apnea
Keywords
nocturnal hypertension, non-dipping blood pressure, obstructive sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover study of high (6 g) and low (1.5 g) sodium diet
Masking
ParticipantInvestigator
Masking Description
Both the participant and investigator are blinded to the diet
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High sodium diet
Arm Type
Experimental
Arm Description
High sodium diet is 6 g sodium per day for 10 days
Arm Title
Low sodium diet
Arm Type
Experimental
Arm Description
Low sodium diet is 1.5 g sodium per day for 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary sodium
Intervention Description
High (6 g) versus low (1.5 g) sodium diet
Primary Outcome Measure Information:
Title
24-hour blood pressure
Description
Blood pressure measured by an ambulatory blood pressure monitor
Time Frame
Baseline to 7 days after start of dietary period
Secondary Outcome Measure Information:
Title
Obstructive sleep apnea
Description
Severity of obstructive sleep apnea as determine by the apnea hypopnea index
Time Frame
Baseline to 7 days after start of dietary period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Calhoun, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
David A. Calhoun, MD
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nocturnal Hypertension and Non-Dipping Blood Pressure
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