HealthyNCT02730780
The Natriuretic Peptide System in African-Americans.
A study testing Low-Salt Diet and High-Salt Diet in people with Healthy and Prehypertension, run by Vanderbilt University at 1 site in United States.
Trial summary
This study aims to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Prehypertension
- What is being tested?
- Low-Salt Diet and High-Salt Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2016to 20 May 2021
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 55 years
- BMI between 18 and <25 kg/m2
- normotensive or pre-hypertensive
- willing to adhere to study diets
Who cannot join
- prevalent cardiovascular disease or use of medications for cardiovascular disease
- Current or prior history of hypertension or use of blood pressure lowering medications
- Current or prior history of diabetes mellitus or use of anti-diabetic medications
- Prevalent renal disease (eGFR < 60 ml/min/1.73m2), abnormal serum sodium or potassium
- Current or prior smoker
- Current pregnancy
- Current steroid use
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals.
Read the detailed description
High blood pressure, or hypertension, is a major cause of heart disease, heart failure, and stroke. Natriuretic peptides are cardiac derived hormones that may protect against hypertension. The classical actions of the natriuretic peptides include natriuresis, vasodilation, and inhibition of the renin-angiotensin-aldosterone system (RAAS), which support a key role for these hormones in blood pressure regulation.
Race based differences exist in the risk and severity of hypertension and cardiovascular disease, with African-American individuals typically being at greater risk compared with white individuals. Nearly half of African-American adults have hypertension, compared with one-third of whites. Additionally, salt-sensitivity denotes the impaired ability to handle a salt load with resulting increases in blood pressure. It is estimated that 75% of hypertensive African-Americans exhibit salt-sensitivity, compared with 35% of hypertensive whites. Why this predilection towards salt-sensitivity exists, particularly among African-American individuals, is not well understood. Thus, establishing the origins of salt retention in African Americans has biologic, preventative, and therapeutic importance, and may provide insight regarding racial differences in cardiovascular risk.
The natriuretic peptide system is the principal counter-regulatory mechanism to salt retention. However, little is known regarding racial differences in the natriuretic peptide system. Recently, it was discovered that African-Americans have lower natriuretic peptide levels compared with whites, raising the possibility that African-Americans individuals can have a relative "natriuretic peptide deficiency" with reduced natriuretic peptide responses to salt loading. However, the prior studies were based on epidemiologic data with individuals on random salt backgrounds. This highlights the need for more detailed physiologic studies, under controlled salt conditions and with standardized assessment of the natriuretic peptide and RAAS and tissue sodium stores.
The aim of this study is to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals. This study will test the primary hypothesis that compared with whites, African-American individuals have blunted natriuretic peptide responses to dietary salt loading.
Secondary hypotheses include:
- Compared with white individuals, African-American individuals have higher baseline tissue sodium content, and
- Compared with white individuals, African-American individuals have impaired "target organ" responses to salt loading, as manifested by higher blood pressure and increased frequency of salt-sensitive hypertension, decreased urinary sodium excretion, less suppression of plasma renin and serum aldosterone, and lack of increase in left ventricular early diastolic relaxation velocities.
- Conditions
- Healthy, Prehypertension
- Being tested
- Low-Salt Diet, High-Salt Diet
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Salt DietDietary supplement
The low-salt diet (7 days) will consist of meals, snacks, and sodium free water provided by the study staff.
High-Salt DietDietary supplement
The high-salt diet (7 days) consists of each subject's usual diet, supplemented each day with 2 bouillon broth packets, which will be provided to the subject by the study staff.
| Study group | Role | What they receive |
|---|---|---|
| African-American | Other | 40 healthy African-American subjects will be enrolled and each will undergo study procedures at 4 separate visits, with each visit occurring 7-days apart. After a baseline visit, the subject will begin either a low-salt or high-salt diet, based upon randomization assignment to one of the two following dietary protocols: A) low-salt diet, washout, then high-salt diet; or B) high-salt diet, washout, then low-salt diet. Each dietary or washout period lasts for 7 days. Receives: Dietary Supplement: Low-Salt Diet; Dietary Supplement: High-Salt Diet |
| Whites | Other | 40 healthy white subjects will be enrolled and each will undergo study procedures at 4 separate visits, with each visit occurring 7-days apart. After a baseline visit, the subject will begin either a low-salt or high-salt diet, based upon randomization assignment to one of the two following dietary protocols: A) low-salt diet, washout, then high-salt diet; or B) high-salt diet, washout, then low-salt diet. Each dietary or washout period lasts for 7 days. Receives: Dietary Supplement: Low-Salt Diet; Dietary Supplement: High-Salt Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in circulating NT-proANP levels in response to low and high dietary salt.
Measured: 4 years
Secondary outcomes (7)
Tissue sodium content
Measured by sodium MRI
Measured: 4 years
Blood pressure
Measured: 4 years
Salt-sensitive hypertension
Measured by change in mean arterial pressure
Measured: 4 years
Urinary sodium excretion
Measured from 24 hour urine collection
Measured: 4 years
Myocardial early relaxation velocities
Measured from Echocardiography as tissue Doppler e'
Measured: 4 years
Plasma renin
Physiological parameter
Measured: 4 years
Serum aldosterone
Physiological parameter
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start22 Jul 2016
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Gupta, Vanderbilt University
- Investigators
- Deepak K Gupta, MD, Principal investigator, Vanderbilt Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730780
- Sponsor's protocol ID
- 151943
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2016
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Gupta DK, de Lemos JA, Ayers CR, Berry JD, Wang TJ. Racial Differences in Natriuretic Peptide Levels: The Dallas Heart Study. JACC Heart Fail. 2015 Jul;3(7):513-519. doi: 10.1016/j.jchf.2015.02.008. Epub 2015 Jun 10.
PubMed 26071618Gupta DK, Claggett B, Wells Q, Cheng S, Li M, Maruthur N, Selvin E, Coresh J, Konety S, Butler KR, Mosley T, Boerwinkle E, Hoogeveen R, Ballantyne CM, Solomon SD. Racial differences in circulating natriuretic peptide levels: the atherosclerosis risk in communities study. J Am Heart Assoc. 2015 May 21;4(5):e001831. doi: 10.1161/JAHA.115.001831.
PubMed 25999400
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natriuretic Peptide System in African-Americans.
- ClinicalTrials.gov ID
- NCT02730780
- Acronym / sponsor ID
- 151943
- Conditions
- Healthy, Prehypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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.
This study aims to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals.
Detailed description
High blood pressure, or hypertension, is a major cause of heart disease, heart failure, and stroke. Natriuretic peptides are cardiac derived hormones that may protect against hypertension. The classical actions of the natriuretic peptides include natriuresis, vasodilation, and inhibition of the renin-angiotensin-aldosterone system (RAAS), which support a key role for these hormones in blood pressure regulation.
Race based differences exist in the risk and severity of hypertension and cardiovascular disease, with African-American individuals typically being at greater risk compared with white individuals. Nearly half of African-American adults have hypertension, compared with one-third of whites. Additionally, salt-sensitivity denotes the impaired ability to handle a salt load with resulting increases in blood pressure. It is estimated that 75% of hypertensive African-Americans exhibit salt-sensitivity, compared with 35% of hypertensive whites. Why this predilection towards salt-sensitivity exists, particularly among African-American individuals, is not well understood. Thus, establishing the origins of salt retention in African Americans has biologic, preventative, and therapeutic importance, and may provide insight regarding racial differences in cardiovascular risk.
The natriuretic peptide system is the principal counter-regulatory mechanism to salt retention. However, little is known regarding racial differences in the natriuretic peptide system. Recently, it was discovered that African-Americans have lower natriuretic peptide levels compared with whites, raising the possibility that African-Americans individuals can have a relative "natriuretic peptide deficiency" with reduced natriuretic peptide responses to salt loading. However, the prior studies were based on epidemiologic data with individuals on random salt backgrounds. This highlights the need for more detailed physiologic studies, under controlled salt conditions and with standardized assessment of the natriuretic peptide and RAAS and tissue sodium stores.
The aim of this study is to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals. This study will test the primary hypothesis that compared with whites, African-American individuals have blunted natriuretic peptide responses to dietary salt loading.
Secondary hypotheses include:
- Compared with white individuals, African-American individuals have higher baseline tissue sodium content, and
- Compared with white individuals, African-American individuals have impaired "target organ" responses to salt loading, as manifested by higher blood pressure and increased frequency of salt-sensitive hypertension, decreased urinary sodium excretion, less suppression of plasma renin and serum aldosterone, and lack of increase in left ventricular early diastolic relaxation velocities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African-American | Other | Dietary Supplement: Low-Salt Diet, Dietary Supplement: High-Salt Diet40 healthy African-American subjects will be enrolled and each will undergo study procedures at 4 separate visits, with each visit occurring 7-days apart. After a baseline visit, the subject will begin either a low-salt or high-salt diet, based upon randomization assignment to one of the two following dietary protocols: A) low-salt diet, washout, then high-salt diet; or B) high-salt diet, washout, then low-salt diet. Each dietary or washout period lasts for 7 days. |
| Whites | Other | Dietary Supplement: Low-Salt Diet, Dietary Supplement: High-Salt Diet40 healthy white subjects will be enrolled and each will undergo study procedures at 4 separate visits, with each visit occurring 7-days apart. After a baseline visit, the subject will begin either a low-salt or high-salt diet, based upon randomization assignment to one of the two following dietary protocols: A) low-salt diet, washout, then high-salt diet; or B) high-salt diet, washout, then low-salt diet. Each dietary or washout period lasts for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 55 years
- BMI between 18 and <25 kg/m2
- normotensive or pre-hypertensive
- willing to adhere to study diets
Key exclusion criteria (8 listed)
- prevalent cardiovascular disease or use of medications for cardiovascular disease
- Current or prior history of hypertension or use of blood pressure lowering medications
- Current or prior history of diabetes mellitus or use of anti-diabetic medications
- Prevalent renal disease (eGFR < 60 ml/min/1.73m2), abnormal serum sodium or potassium
- Current or prior smoker
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 |
|---|---|---|
| Low-Salt DietThe low-salt diet (7 days) will consist of meals, snacks, and sodium free water provided by the study staff. | Dietary supplement | African-American, Whites |
| High-Salt DietThe high-salt diet (7 days) consists of each subject's usual diet, supplemented each day with 2 bouillon broth packets, which will be provided to the subject by the study staff. | Dietary supplement | African-American, Whites |
Primary outcome
The difference in circulating NT-proANP levels in response to low and high dietary salt.
Time frame: 4 years
7 secondary outcomes
Tissue sodium content
Time frame: 4 years
Blood pressure
Time frame: 4 years
Salt-sensitive hypertension
Time frame: 4 years
Urinary sodium excretion
Time frame: 4 years
Myocardial early relaxation velocities
Time frame: 4 years
Plasma renin
Time frame: 4 years
Serum aldosterone
Time frame: 4 years
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 9 Nov 2022.
- Background: PubMed 26071618Gupta DK, de Lemos JA, Ayers CR, Berry JD, Wang TJ. Racial Differences in Natriuretic Peptide Levels: The Dallas Heart Study. JACC Heart Fail. 2015 Jul;3(7):513-519. doi: 10.1016/j.jchf.2015.02.008. Epub 2015 Jun 10.
- Background: PubMed 25999400Gupta DK, Claggett B, Wells Q, Cheng S, Li M, Maruthur N, Selvin E, Coresh J, Konety S, Butler KR, Mosley T, Boerwinkle E, Hoogeveen R, Ballantyne CM, Solomon SD. Racial differences in circulating natriuretic peptide levels: the atherosclerosis risk in communities study. J Am Heart Assoc. 2015 May 21;4(5):e001831. doi: 10.1161/JAHA.115.001831.
- Individual participant dataSharing planned: Yes
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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.
Deepak K Gupta, MD principal investigator
Vanderbilt Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Salt Diet and High-Salt Diet in people with Healthy and Prehypertension, run by Vanderbilt University 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 4 inclusion and 8 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 9 Nov 2022. 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?
The difference in circulating NT-proANP levels in response to low and high dietary salt. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730780, which also lists 2 linked publications.
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 9 Nov 2022.