HyperaldosteronismNCT00001176
Effects of Salt Intake on the Nervous Systems of Patients With Salt-Sensitive High Blood Pressure
An observational study of Hyperaldosteronism and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Some patients with high blood pressure can experience an increase of blood pressure by 10 percent or more by taking in salt. These patients are referred to as having "salt-sensitive" (SS) hypertension. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hyperaldosteronism, Hypertension
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- May 1981to Dec 2001
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Eligibility criteria not identified in protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: The Function of Dopaminergic and Noradrenergic Systems in Salt-Sensitive Hypertension: The Effects of Changes in Sodium Intake
Some patients with high blood pressure can experience an increase of blood pressure by 10 percent or more by taking in salt. These patients are referred to as having "salt-sensitive" (SS) hypertension.
Previous studies conducted on patients with salt sensitive hypertension suggest that their portion of the nervous system responsible for maintaining normal blood pressure (autonomic nervous system) may respond differently to salt than patients with non-salt sensitive (NSS) hypertension.
This study is designed to examine the response of the nervous system to high doses of salt in patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.
Read the detailed description
A subset of patients with idiopathic hypertension shows an increase in blood pressure of 10 percent or more in response to salt-loading and have been termed "salt-sensitive" (SS). Limited studies of adrenergic function in response to salt-loading suggest that the response of SS patients may differ from that of non-salt sensitive (NSS) patients. The present studies were designed to examine the response of the adrenergic and dopaminergic systems to salt-loading in SS and NSS patients with idiopathic hypertension.
- Conditions
- Hyperaldosteronism, Hypertension
- Keywords
- Adrenergic Nervous System, Dopaminergic Nervous System, Salt-Sensitive Hypertension, Hypertension, Primary Aldosteronism
- Medical subject headings
- Hyperaldosteronism, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMay 1981
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Observational
- Enrolment
- 110 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001176
- Sponsor's protocol ID
- 810081
- Other IDs
- 81-H-0081
- Status last verified
- Dec 2001
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kawasaki T, Delea CS, Bartter FC, Smith H. The effect of high-sodium and low-sodium intakes on blood pressure and other related variables in human subjects with idiopathic hypertension. Am J Med. 1978 Feb;64(2):193-8. doi: 10.1016/0002-9343(78)90045-1.
PubMed 629267Fujita T, Henry WL, Bartter FC, Lake CR, Delea CS. Factors influencing blood pressure in salt-sensitive patients with hypertension. Am J Med. 1980 Sep;69(3):334-44. doi: 10.1016/0002-9343(80)90002-9. No abstract available.
PubMed 6998291Alexander RW, Gill JR Jr, Yamabe H, Lovenberg W, Keiser HR. Effects of dietary sodium and of acute saline infusion on the interrelationship between dopamine excretion and adrenergic activity in man. J Clin Invest. 1974 Jul;54(1):194-200. doi: 10.1172/JCI107743.
PubMed 4600048
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Function of Dopaminergic and Noradrenergic Systems in Salt-Sensitive Hypertension: The Effects of Changes in Sodium Intake
- ClinicalTrials.gov ID
- NCT00001176
- Acronym / sponsor ID
- 810081
- Conditions
- Hyperaldosteronism, Hypertension
- Keywords
- Adrenergic Nervous System, Dopaminergic Nervous System, Salt-Sensitive Hypertension, Hypertension, Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1981
- Study completion
- Dec 2001
- First posted
- 4 Nov 1999 (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.
Some patients with high blood pressure can experience an increase of blood pressure by 10 percent or more by taking in salt. These patients are referred to as having "salt-sensitive" (SS) hypertension.
Previous studies conducted on patients with salt sensitive hypertension suggest that their portion of the nervous system responsible for maintaining normal blood pressure (autonomic nervous system) may respond differently to salt than patients with non-salt sensitive (NSS) hypertension.
This study is designed to examine the response of the nervous system to high doses of salt in patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.
Detailed description
A subset of patients with idiopathic hypertension shows an increase in blood pressure of 10 percent or more in response to salt-loading and have been termed "salt-sensitive" (SS). Limited studies of adrenergic function in response to salt-loading suggest that the response of SS patients may differ from that of non-salt sensitive (NSS) patients. The present studies were designed to examine the response of the adrenergic and dopaminergic systems to salt-loading in SS and NSS patients with idiopathic hypertension.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 629267Kawasaki T, Delea CS, Bartter FC, Smith H. The effect of high-sodium and low-sodium intakes on blood pressure and other related variables in human subjects with idiopathic hypertension. Am J Med. 1978 Feb;64(2):193-8. doi: 10.1016/0002-9343(78)90045-1.
- Background: PubMed 6998291Fujita T, Henry WL, Bartter FC, Lake CR, Delea CS. Factors influencing blood pressure in salt-sensitive patients with hypertension. Am J Med. 1980 Sep;69(3):334-44. doi: 10.1016/0002-9343(80)90002-9. No abstract available.
- Background: PubMed 4600048Alexander RW, Gill JR Jr, Yamabe H, Lovenberg W, Keiser HR. Effects of dietary sodium and of acute saline infusion on the interrelationship between dopamine excretion and adrenergic activity in man. J Clin Invest. 1974 Jul;54(1):194-200. doi: 10.1172/JCI107743.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyperaldosteronism and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001176, which also lists 3 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 4 Mar 2008.