Nocturnal Hypertension and Non-Dipping Blood Pressure | NCT03128177

Studies
Nocturnal Hypertension and Non-Dipping Blood Pressure

NCT03128177

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Jun 11, 2020Actual

Enrollment

59Actual

Phase

Not Applicable

Conditions

Hypertension
Obstructive Sleep Apnea

Interventions

Dietary sodium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Apr 20, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2020

Last Update Posted Date

Jun 11, 2020Actual

Name	Class
American Heart Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High sodium diet	Experimental	High sodium diet is 6 g sodium per day for 10 days	Dietary Supplement: Dietary sodium
Low sodium diet	Experimental	Low sodium diet is 1.5 g sodium per day for 10 days	Dietary Supplement: Dietary sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary sodium	Dietary Supplement	High (6 g) versus low (1.5 g) sodium diet	High sodium diet Low sodium diet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

48 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Calhoun, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David A. Calhoun, MD		Birmingham	Alabama	35294	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012891	Sleep Apnea Syndromes
D001049	Apnea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012982	Sodium, Dietary

Ancestor Terms

ID	Term
D017670	Sodium Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided