Salt-sensitive HypertensionSaltNCT01324245
Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet
A study testing Fenoldopam in people with Salt-sensitive Hypertension, run by Georgetown University at 1 site in United States.
Trial summary
The kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt-sensitive Hypertension
- What is being tested?
- Fenoldopam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to May 2006
- 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
- Volunteers
- Healthy
- Normal Blood Pressure
Who cannot join
- Renal Impairment
- Obesity
- Salt sensitive increase in blood pressure
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Paracrine Regulation of Renal Function by Dopamine in Normotensive Humans
The kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. We hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor, Enalapril.
In this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.
Read the detailed description
Eight adults of both genders and all races were studied in this double blind placebo controlled cross over study with randomization of the order of interventions. After 5 days each on low salt (about 1 gram/day) and high salt (about 6 grams/day)diet, with a washout period of at least four weeks in between, every subject was treated with Enalapril and Placebo on two consecutive days, followed by a Fenoldopam infusion for three hours, during which natriuresis and renal function testing were performed.
- Conditions
- Salt-sensitive Hypertension
- Being tested
- Fenoldopam
- Keywords
- Salt, Balance, Renin Angiotensin System, Fenoldopam\blood Pressure, Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenoldopamDrug
Also called Enalaprilat, Corlopam
Intravenous infusion at 0.5 mics/Kg/min for three hours
| Study group | Role | What they receive |
|---|---|---|
| Enalapril | Experimental | 2.5 mg every 12 hours for two doses Receives: Drug: Fenoldopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium excretion
All subjects received placebo/enalapril in a randomized counterbalanced fashion in both phases. Phase 1 was on low salt, while Phase 2 was on high salt. All subjects received a 3 hour fenoldopam infusion, during which time urinary sodium excretion was measured as the primary outcome bvariable.
Measured: During the trial: a 3 hour fenoldopam infusion
Secondary outcomes (1)
Renal Plasma Flow
In order to explain physiologically the effects of fenoldopam on urinary sodium excretion on high and low salt diet, with and wothout enalapril, renal plasma flow was measured during the infusion using PAH clearance
Measured: During 3 hour fenoldopam infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startNov 2002
- Primary completionDec 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt-sensitive HypertensionStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Investigators
- Aruna R Natarajan, MD, PhD, Principal investigator, Georgetown University HospitalPedro A Jose, MD, PhD, Study director, Georgetown University/ George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324245
- Sponsor's protocol ID
- 2003-142
- Other IDs
- RR 17613
- Acronym
- Salt
- Status last verified
- Nov 2003
- First submitted
- 25 Mar 2011
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracrine Regulation of Renal Function by Dopamine in Normotensive Humans
- ClinicalTrials.gov ID
- NCT01324245
- Acronym / sponsor ID
- Salt / 2003-142
- Conditions
- Salt-sensitive Hypertension
- Keywords
- Salt, Balance, Renin Angiotensin System, Fenoldopam\blood Pressure, Sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- Nov 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 28 Mar 2011 (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 kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. We hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor, Enalapril.
In this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.
Detailed description
Eight adults of both genders and all races were studied in this double blind placebo controlled cross over study with randomization of the order of interventions. After 5 days each on low salt (about 1 gram/day) and high salt (about 6 grams/day)diet, with a washout period of at least four weeks in between, every subject was treated with Enalapril and Placebo on two consecutive days, followed by a Fenoldopam infusion for three hours, during which natriuresis and renal function testing were performed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enalapril | Experimental | Drug: Fenoldopam2.5 mg every 12 hours for two doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteers
- Healthy
- Normal Blood Pressure
Key exclusion criteria (3 listed)
- Renal Impairment
- Obesity
- Salt sensitive increase in blood pressure
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 |
|---|---|---|
| FenoldopamAlso: Enalaprilat, CorlopamIntravenous infusion at 0.5 mics/Kg/min for three hours | Drug | Enalapril |
Primary outcome
Urinary sodium excretion
Time frame: During the trial: a 3 hour fenoldopam infusion
All subjects received placebo/enalapril in a randomized counterbalanced fashion in both phases. Phase 1 was on low salt, while Phase 2 was on high salt. All subjects received a 3 hour fenoldopam infusion, during which time urinary sodium excretion was measured as the primary outcome bvariable.
1 secondary outcome
Renal Plasma Flow
Time frame: During 3 hour fenoldopam infusion
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 28 Mar 2011.
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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.
Aruna R Natarajan, MD, PhD principal investigator
Georgetown University Hospital
Pedro A Jose, MD, PhD study director
Georgetown University/ George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenoldopam in people with Salt-sensitive Hypertension, run by Georgetown 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 3 inclusion and 3 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 28 Mar 2011. 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?
Urinary sodium excretion (time frame: During the trial: a 3 hour fenoldopam infusion). 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 28 Mar 2011.