HypertensionNCT03128177
Nocturnal Hypertension and Non-Dipping Blood Pressure
A study testing Dietary sodium in people with Hypertension and Obstructive Sleep Apnea, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 48 to 65 years
- Conditions the study is for
- Hypertension, Obstructive Sleep Apnea
- What is being tested?
- Dietary sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nocturnal hypertension
Who cannot join
- Stage 2 clinic hypertension
- History of congestive heart failure
- Chronic kidney disease,
- Diabetes with insulin use
- History of a cardiovascular event
- Pregnant or nursing
Show all 9Show fewer
- Current use of continuous positive airway pressure
- Shift work
- A known circadian rhythm disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns
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.
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Being tested
- Dietary sodium
- Keywords
- nocturnal hypertension, non-dipping blood pressure, obstructive sleep apnea
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary sodiumDietary supplement
High (6 g) versus low (1.5 g) sodium diet
| Study group | Role | What they receive |
|---|---|---|
| High sodium diet | Experimental | High sodium diet is 6 g sodium per day for 10 days Receives: Dietary Supplement: Dietary sodium |
| Low sodium diet | Experimental | Low sodium diet is 1.5 g sodium per day for 10 days Receives: Dietary Supplement: Dietary sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour blood pressure
Blood pressure measured by an ambulatory blood pressure monitor
Measured: Baseline to 7 days after start of dietary period
Secondary outcomes (1)
Obstructive sleep apnea
Severity of obstructive sleep apnea as determine by the apnea hypopnea index
Measured: Baseline to 7 days after start of dietary period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Jan 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study of high (6 g) and low (1.5 g) sodium diet
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, David Calhoun, University of Alabama at Birmingham
- Investigators
- David Calhoun, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128177
- Sponsor's protocol ID
- F150508004
- Status last verified
- Jun 2020
- First submitted
- 20 Apr 2017
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns
- ClinicalTrials.gov ID
- NCT03128177
- Acronym / sponsor ID
- F150508004
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- nocturnal hypertension, non-dipping blood pressure, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover study of high (6 g) and low (1.5 g) sodium diet
| Arm | Type | Receives |
|---|---|---|
| High sodium diet | Experimental | Dietary Supplement: Dietary sodiumHigh sodium diet is 6 g sodium per day for 10 days |
| Low sodium diet | Experimental | Dietary Supplement: Dietary sodiumLow sodium diet is 1.5 g sodium per day for 10 days |
Who may qualify
- Ages
- 48 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nocturnal hypertension
Key exclusion criteria (9 listed)
- Stage 2 clinic hypertension
- History of congestive heart failure
- Chronic kidney disease,
- Diabetes with insulin use
- History of a cardiovascular event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary sodiumHigh (6 g) versus low (1.5 g) sodium diet | Dietary supplement | High sodium diet, Low sodium diet |
Primary outcome
24-hour blood pressure
Time frame: Baseline to 7 days after start of dietary period
Blood pressure measured by an ambulatory blood pressure monitor
1 secondary outcome
Obstructive sleep apnea
Time frame: Baseline to 7 days after start of dietary period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Calhoun, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary sodium in people with Hypertension and Obstructive Sleep Apnea, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour blood pressure (time frame: Baseline to 7 days after start of dietary period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.