Hypertension UncomplicatedNCT03147170
A Biomarker to Detect Salt Sensitivity
An observational study of Hypertension Uncomplicated and Pre Hypertension, run by University of Minnesota at 1 site in United States.
Trial summary
The investigators are proposing that individuals with elevated levels of NT-proBNP are resistant to natriuretic peptides and are unable to handle sodium loads and maintain optimal blood pressure values.The investigators will test this hypothesis by comparing the blood pressure response to low and high salt diets in… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension Uncomplicated, Pre Hypertension
- What is being tested?
- High and low salt diets
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Observational
- 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 30 to 75 years
- All sexes
- Adult, Older adult
Study population: Pre- or hypertensive individuals without chronic complications, between the ages of 30 and 75 years, not on blood pressure lowering medications.
Who may be able to join
- Systolic blood pressure > 120 and < 160 mmHg
- Diastolic blood pressure > 80 and < 100 mmHg
- Not on hypertensive medications
- NT-proBNP between 40 - 99 pg/mL (healthy levels)
- NT-proBNP > 120 pg/mL (elevated levels)
Who cannot join
- Physician reported diabetes or on insulin or oral hypoglycemic agents
- BMI > 40kg/m2
- Age < 30 or > 75 years
- Presence of cardiovascular disease or chronic kidney disease
- Chronic obstructive pulmonary disease or pulmonary arterial hypertension
- Aldosterone secreting disorder
Show all 9Show fewer
- Estimated energy intake greater than 3400 calories
- Pregnancy
- Individuals with pacemakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Use of NT-proBNP as a Biomarker to Treat Salt Sensitive in Hypertensive Individuals
The investigators are proposing that individuals with elevated levels of NT-proBNP are resistant to natriuretic peptides and are unable to handle sodium loads and maintain optimal blood pressure values.The investigators will test this hypothesis by comparing the blood pressure response to low and high salt diets in individuals with pre- or hypertension and who have normal or elevated levels of NT-proBNP. The investigators expect that blood pressure values in those with normal levels of NT-proBNP will not change with high salt diets, whereas, in those with elevated levels of NT-proBNP, blood pressure values will increase significantly when exposed to high salt diets.
Read the detailed description
Natriuretic peptides (NPs) are molecules that regulate blood pressure by inducing natriuresis and vasodilation. We have shown that higher baseline levels of NT-proBNP are associated with the development of hypertension and humans elevated NT-proBNP levels demonstrate resistance to the action of NPs and are unable to handle high dietary sodium loads. These findings have led us to propose that pre-hypertensive or newly diagnose hypertensive individuals, free of overt cardiovascular disease, who have elevated levels of NT-proBNP will experience a substantial rise in total body water and arterial blood pressure when exposed to a high sodium load. If this hypothesis holds true, then NT-proBNP could be used as a biological marker to identify salt sensitivity and for the prescription of low sodium diets to hypertensive individuals.
Research design: Individuals with physiological levels of NT-proBNP (40 - 90 pg/mL) and those with elevated levels (> 120 pg/mL) will be recruited to participate in a randomized crossover feeding study designed to treat patients with hypertension. A total of 8 participants, per group, will be exposed to two 10 days-phases of either a low sodium load (LS) of 50 mmol/day or a high sodium load (HS) of 250 mmol/day in random order and compare the blood pressure response to different sodium loads between the two NT-proBNP categories. Salt sensitivity is defined as a change in mean arterial blood pressure of ≥ 10% between the low and high sodium load. At the end of each phase, participants will be tested on a variety of anthropometric, blood and urinary measurements.
Variables measured: Total body water will be determined using bioelectrical impedance from Valhalla Scientific body comp scale®. Blood pressure monitors will be provided to each participant for measurement and record their own blood pressure twice daily for the duration of the study. In addition, at the end of each of the two sodium loading phases, trained personnel will measure BP three time using standard procedures, following an 8 hour fast and a 10 minute rest period at the clinic. Laboratory measurements. Blood and urine analysis will be performed at the start and end of each salt loading phase at the Advanced Research and Diagnostic Laboratory (ARDL). NT-proBNP will be measured using the Roche-Elecsys proBNP® (Roche Diagnostics, Indianapolis, IN). This method has a range of values that extends from 1 - 25000 pg/mL and the intra-assay precision is below 4% and the CV and interassay precision below 5% 21. Plasma BNP will be measured on a Siemens Advia Centaur instrument using a chemiluminescent immunoassay which has a minimal detection limit of 1.9 pg/mL and a CV of 3.4%. cGMP will be measured using a competitive enzyme immunoassay by Bio-Techne (Minneapolis, MN) intra essay CV is 7%. NT-proBNP will be measured using the Roche-Elecsys proBNP® (Roche Diagnostics, Indianapolis, IN). This method has a range of values that extends from 1 - 25000 pg/mL and the intra-assay precision is below 4% CV and inter-assay precision below 5% 21.
Anticipated results and future studies. Individuals with elevated NT-proBNP will have a significant increase in mean blood pressure and total body water (salt sensitive individuals) and a greater BNP/cGMP ratio when compared to those with physiological levels of NT-proBNP.
Power analysis shows that for a randomized cross-over study we would need 25 individuals per group for a 90% power.
- Conditions
- Hypertension Uncomplicated, Pre Hypertension
- Being tested
- High and low salt diets
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High and low salt dietsDiagnostic test
Effects of high and low salt diets on blood pressure in individuals with normal and elevated levels of NT-proBNP
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Difference in blood pressure before and after diets periods and comparison between those with normal and elevated blood levels of NT-proBNP.
Measured: 9 weeks
Secondary outcomes (1)
Ratio of BNP/cGMP
Difference in BNP/cGMP before and after diets periods and comparison between those with normal and elevated blood levels of NT-proBNP.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jan 2016
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension UncomplicatedStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Otto A Sanchez, MD PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147170
- Sponsor's protocol ID
- 1512M81431
- Status last verified
- Apr 2019
- First submitted
- 8 May 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NT-proBNP as a Biomarker to Treat Salt Sensitive in Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT03147170
- Acronym / sponsor ID
- 1512M81431
- Conditions
- Hypertension Uncomplicated, Pre Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 May 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 investigators are proposing that individuals with elevated levels of NT-proBNP are resistant to natriuretic peptides and are unable to handle sodium loads and maintain optimal blood pressure values.The investigators will test this hypothesis by comparing the blood pressure response to low and high salt diets in individuals with pre- or hypertension and who have normal or elevated levels of NT-proBNP. The investigators expect that blood pressure values in those with normal levels of NT-proBNP will not change with high salt diets, whereas, in those with elevated levels of NT-proBNP, blood pressure values will increase significantly when exposed to high salt diets.
Detailed description
Natriuretic peptides (NPs) are molecules that regulate blood pressure by inducing natriuresis and vasodilation. We have shown that higher baseline levels of NT-proBNP are associated with the development of hypertension and humans elevated NT-proBNP levels demonstrate resistance to the action of NPs and are unable to handle high dietary sodium loads. These findings have led us to propose that pre-hypertensive or newly diagnose hypertensive individuals, free of overt cardiovascular disease, who have elevated levels of NT-proBNP will experience a substantial rise in total body water and arterial blood pressure when exposed to a high sodium load. If this hypothesis holds true, then NT-proBNP could be used as a biological marker to identify salt sensitivity and for the prescription of low sodium diets to hypertensive individuals.
Research design: Individuals with physiological levels of NT-proBNP (40 - 90 pg/mL) and those with elevated levels (> 120 pg/mL) will be recruited to participate in a randomized crossover feeding study designed to treat patients with hypertension. A total of 8 participants, per group, will be exposed to two 10 days-phases of either a low sodium load (LS) of 50 mmol/day or a high sodium load (HS) of 250 mmol/day in random order and compare the blood pressure response to different sodium loads between the two NT-proBNP categories. Salt sensitivity is defined as a change in mean arterial blood pressure of ≥ 10% between the low and high sodium load. At the end of each phase, participants will be tested on a variety of anthropometric, blood and urinary measurements.
Variables measured: Total body water will be determined using bioelectrical impedance from Valhalla Scientific body comp scale®. Blood pressure monitors will be provided to each participant for measurement and record their own blood pressure twice daily for the duration of the study. In addition, at the end of each of the two sodium loading phases, trained personnel will measure BP three time using standard procedures, following an 8 hour fast and a 10 minute rest period at the clinic. Laboratory measurements. Blood and urine analysis will be performed at the start and end of each salt loading phase at the Advanced Research and Diagnostic Laboratory (ARDL). NT-proBNP will be measured using the Roche-Elecsys proBNP® (Roche Diagnostics, Indianapolis, IN). This method has a range of values that extends from 1 - 25000 pg/mL and the intra-assay precision is below 4% and the CV and interassay precision below 5% 21. Plasma BNP will be measured on a Siemens Advia Centaur instrument using a chemiluminescent immunoassay which has a minimal detection limit of 1.9 pg/mL and a CV of 3.4%. cGMP will be measured using a competitive enzyme immunoassay by Bio-Techne (Minneapolis, MN) intra essay CV is 7%. NT-proBNP will be measured using the Roche-Elecsys proBNP® (Roche Diagnostics, Indianapolis, IN). This method has a range of values that extends from 1 - 25000 pg/mL and the intra-assay precision is below 4% CV and inter-assay precision below 5% 21.
Anticipated results and future studies. Individuals with elevated NT-proBNP will have a significant increase in mean blood pressure and total body water (salt sensitive individuals) and a greater BNP/cGMP ratio when compared to those with physiological levels of NT-proBNP.
Power analysis shows that for a randomized cross-over study we would need 25 individuals per group for a 90% power.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pre- or hypertensive individuals without chronic complications, between the ages of 30 and 75 years, not on blood pressure lowering medications.
Key inclusion criteria (5 listed)
- Systolic blood pressure > 120 and < 160 mmHg
- Diastolic blood pressure > 80 and < 100 mmHg
- Not on hypertensive medications
- NT-proBNP between 40 - 99 pg/mL (healthy levels)
- NT-proBNP > 120 pg/mL (elevated levels)
Key exclusion criteria (9 listed)
- Physician reported diabetes or on insulin or oral hypoglycemic agents
- BMI > 40kg/m2
- Age < 30 or > 75 years
- Presence of cardiovascular disease or chronic kidney disease
- Chronic obstructive pulmonary disease or pulmonary arterial hypertension
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 |
|---|---|---|
| High and low salt dietsEffects of high and low salt diets on blood pressure in individuals with normal and elevated levels of NT-proBNP | Diagnostic test | – |
Primary outcome
Change in blood pressure
Time frame: 9 weeks
Difference in blood pressure before and after diets periods and comparison between those with normal and elevated blood levels of NT-proBNP.
1 secondary outcome
Ratio of BNP/cGMP
Time frame: 9 weeks
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided
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.
Otto A Sanchez, MD PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Uncomplicated and Pre Hypertension, run by University of Minnesota 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 5 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 18 Apr 2019. 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?
Change in blood pressure (time frame: 9 weeks). 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 18 Apr 2019.