HypertensionNCT00800228
Salt Study: Inhibited Breathing Pattern and Sodium Inhibitors in Sodium Sensitivity of Blood Pressure
An observational study of Hypertension, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that blood pressure sensitivity to high sodium intake in healthy humans is characterized by increased urinary excretion of two endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Dec 2006
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community
Who may be able to join
- Age 40-70
- Caucasian
- Nonsmoking
- Free of respiratory, cardiac, liver and kidney disease, and diabetes
- Resting systolic blood pressure less than or equal to 139 mmHg AND resting diastolic blood pressure of less than or equal to 89 mmHg15
- BMI less than or equal to 30
Show all 10Show fewer
- Negative pregnancy test for female participants whose last menstrual period was less than one year prior to study enrollment
- For Group 1, willing to provide 24-hr urine samples for 12 consecutive days
- For Group 2, women on combination oral contraceptives (those containing estrogen and progesterone) will be eligible for the study, with equal numbers in the "fast" and "slow" breathing groups
- For Group 2, in premenopausal women, regular menstrual cycles for at least 6 months prior to study entry
Who cannot join
- Presence of respiratory, cardiac, liver or kidney disease; diabetes, or hypertension
- Use of medications which can affect respiratory rate, such as major tranquilizers, narcotics, or benzodiazepines
- Diuretic or steroid use
- Cigarette smoking within the past 12 months
- BMI > 30 kg/m2
- Postmenopausal women on hormone replacement therapy
Show all 10Show fewer
- Pregnancy or lactation in the last 12 months
- In premenopausal women, irregular menstrual cycles in the 6 months prior to study entry
- For Group 2, respiratory rate in the middle third of the distribution of breathing frequency in BLSA
- For Group 2, pre-menopausal women not taking oral contraceptives who are in the follicular phase of the menstrual cycle
Trial locations and contacts
1 site in 1 country.
United States1 site
NIA Clinical Research Unit
Baltimore, Maryland, 21225
About this study
Official title: Inhibited Breathing Pattern and Sodium Inhibitors in Sodium Sensitivity of Blood Pressure
The purpose of this study is to test the hypothesis that blood pressure sensitivity to high sodium intake in healthy humans is characterized by increased urinary excretion of two endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC). The study also tests the hypothesis that women who breathe slowly and have high resting end tidal CO2 at rest are more likely to have low plasma renin activity and sodium sensitivity of blood pressure than those who breathe more rapidly and maintain lower end tidal CO2.
Read the detailed description
The experiments will involve a common procedure of sodium restriction followed by sodium loading of normotensive (having normal blood pressure) humans. However, the first experiment will involve continuous urine collection throughout the experimental period in a smaller group of men and women, while the second experiment will involve urine collection only at the end of each diet period in a larger group of normotensive women. If, as expected, experiment one shows that sodium loading produces MBG increases that are sustained throughout the sodium loading period, then experiment two will also be able to address a third issue: that is whether MBG or OLC response to sodium loading is specific to breathing pattern or sodium sensitivity. It is hypothesized that women with inhibited breathing who are sodium sensitive will show higher levels of MBG, even before sodium loading, but also following sodium loading.
Each participant will be seen at the Clinical Research Unit for a screening visit and on days 6 and 12, and consume a low sodium diet for 6 days followed by a high sodium diet for 6 days. Research staff will meet with the participant at regular intervals for meal provision and transfer of 24-hr urine collections (if applicable). Respiration and blood pressure will be measured on the last day of each sodium diet.
- Conditions
- Hypertension
- Keywords
- salt, blood pressure, breathing
- Medical subject headings
- Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Eight men and eight women to define the time course of changes in MBG \ and OLC accompanying sodium loading | |
| 2 | 32 additional women to determine whether breathing pattern is predictive of sodium sensitivity in that gender. Women are being studied in the second experiment because they, but not men, have been shown to have an association of breathing pattern with high perceived stress11 and an association of high resting end tidal CO2 with high resting blood pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sodium loading procedures will be identical in both experiments, except that 24-hr urine collection will be collected all 12 days in experiment one, but only on the last two days of each sodium diet in experiment two.
Measured: Group 1- daily; Group 2 - days 6 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startMar 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- David Anderson, PhD, Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800228
- Sponsor's protocol ID
- AG0110
- Status last verified
- Nov 2008
- First submitted
- 30 Nov 2008
- Last updated
- 2 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Muntzel M, Drueke T. A comprehensive review of the salt and blood pressure relationship. Am J Hypertens. 1992 Apr;5(4 Pt 1):1S-42S. doi: 10.1093/ajh/5.4s.1s.
PubMed 1599633Haddy FJ. Digitalislike circulating factor in hypertension: potential messenger between salt balance and intracellular sodium. Cardiovasc Drugs Ther. 1990 Mar;4 Suppl 2:343-9. doi: 10.1007/BF02603174.
PubMed 2176807Doris PA, Bagrov AY. Endogenous sodium pump inhibitors and blood pressure regulation: an update on recent progress. Proc Soc Exp Biol Med. 1998 Jul;218(3):156-67. doi: 10.3181/00379727-218-44283.
PubMed 9648933Fedorova OV, Anderson DE, Lakatta EG, Bagrov AY. Interaction of NaCl and behavioral stress on endogenous sodium pump ligands in rats. Am J Physiol Regul Integr Comp Physiol. 2001 Jul;281(1):R352-8. doi: 10.1152/ajpregu.2001.281.1.R352.
PubMed 11404312
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibited Breathing Pattern and Sodium Inhibitors in Sodium Sensitivity of Blood Pressure
- ClinicalTrials.gov ID
- NCT00800228
- Acronym / sponsor ID
- AG0110
- Conditions
- Hypertension
- Keywords
- salt, blood pressure, breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 2 Dec 2008 (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.
The purpose of this study is to test the hypothesis that blood pressure sensitivity to high sodium intake in healthy humans is characterized by increased urinary excretion of two endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC). The study also tests the hypothesis that women who breathe slowly and have high resting end tidal CO2 at rest are more likely to have low plasma renin activity and sodium sensitivity of blood pressure than those who breathe more rapidly and maintain lower end tidal CO2.
Detailed description
The experiments will involve a common procedure of sodium restriction followed by sodium loading of normotensive (having normal blood pressure) humans. However, the first experiment will involve continuous urine collection throughout the experimental period in a smaller group of men and women, while the second experiment will involve urine collection only at the end of each diet period in a larger group of normotensive women. If, as expected, experiment one shows that sodium loading produces MBG increases that are sustained throughout the sodium loading period, then experiment two will also be able to address a third issue: that is whether MBG or OLC response to sodium loading is specific to breathing pattern or sodium sensitivity. It is hypothesized that women with inhibited breathing who are sodium sensitive will show higher levels of MBG, even before sodium loading, but also following sodium loading.
Each participant will be seen at the Clinical Research Unit for a screening visit and on days 6 and 12, and consume a low sodium diet for 6 days followed by a high sodium diet for 6 days. Research staff will meet with the participant at regular intervals for meal provision and transfer of 24-hr urine collections (if applicable). Respiration and blood pressure will be measured on the last day of each sodium diet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Eight men and eight women to define the time course of changes in MBG \ and OLC accompanying sodium loading |
| 2 | – | –32 additional women to determine whether breathing pattern is predictive of sodium sensitivity in that gender. Women are being studied in the second experiment because they, but not men, have been shown to have an association of breathing pattern with high perceived stress11 and an association of high resting end tidal CO2 with high resting blood pressure. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community
Key inclusion criteria (10 listed)
- Age 40-70
- Caucasian
- Nonsmoking
- Free of respiratory, cardiac, liver and kidney disease, and diabetes
- Resting systolic blood pressure less than or equal to 139 mmHg AND resting diastolic blood pressure of less than or equal to 89 mmHg15
Key exclusion criteria (10 listed)
- Presence of respiratory, cardiac, liver or kidney disease; diabetes, or hypertension
- Use of medications which can affect respiratory rate, such as major tranquilizers, narcotics, or benzodiazepines
- Diuretic or steroid use
- Cigarette smoking within the past 12 months
- BMI > 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sodium loading procedures will be identical in both experiments, except that 24-hr urine collection will be collected all 12 days in experiment one, but only on the last two days of each sodium diet in experiment two.
Time frame: Group 1- daily; Group 2 - days 6 & 12
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 2 Dec 2008.
- Background: PubMed 1599633Muntzel M, Drueke T. A comprehensive review of the salt and blood pressure relationship. Am J Hypertens. 1992 Apr;5(4 Pt 1):1S-42S. doi: 10.1093/ajh/5.4s.1s.
- Background: PubMed 2176807Haddy FJ. Digitalislike circulating factor in hypertension: potential messenger between salt balance and intracellular sodium. Cardiovasc Drugs Ther. 1990 Mar;4 Suppl 2:343-9. doi: 10.1007/BF02603174.
- Background: PubMed 9648933Doris PA, Bagrov AY. Endogenous sodium pump inhibitors and blood pressure regulation: an update on recent progress. Proc Soc Exp Biol Med. 1998 Jul;218(3):156-67. doi: 10.3181/00379727-218-44283.
- Background: PubMed 11404312Fedorova OV, Anderson DE, Lakatta EG, Bagrov AY. Interaction of NaCl and behavioral stress on endogenous sodium pump ligands in rats. Am J Physiol Regul Integr Comp Physiol. 2001 Jul;281(1):R352-8. doi: 10.1152/ajpregu.2001.281.1.R352.
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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 Anderson, PhD principal investigator
National Institute on Aging (NIA)
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, run by National Institute on Aging (NIA) 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 10 inclusion and 10 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 2 Dec 2008. 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 sodium loading procedures will be identical in both experiments, except that 24-hr urine collection will be collected all 12 days in experiment one, but only on the last two days of each sodium diet in experiment two. (time frame: Group 1- daily; Group 2 - days 6 & 12). 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 NCT00800228, which also lists 4 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 2 Dec 2008.