Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet
Salt
Paracrine Regulation of Renal Function by Dopamine in Normotensive Humans
2 other identifiers
interventional
45
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 28, 2011
CompletedMarch 28, 2011
November 1, 2003
3.1 years
March 25, 2011
March 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
During the trial: a 3 hour fenoldopam infusion
Secondary Outcomes (1)
Renal Plasma Flow
During 3 hour fenoldopam infusion
Study Arms (1)
Enalapril
EXPERIMENTAL2.5 mg every 12 hours for two doses
Interventions
Intravenous infusion at 0.5 mics/Kg/min for three hours
Eligibility Criteria
You may qualify if:
- Volunteers
- Healthy
- Normal Blood Pressure
You may not qualify if:
- Renal Impairment
- Obesity
- Salt sensitive increase in blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- University of Virginiacollaborator
Study Sites (1)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aruna R Natarajan, MD, PhD
Georgetown University Hospital
- STUDY DIRECTOR
Pedro A Jose, MD, PhD
Georgetown University/ George Washington University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 25, 2011
First Posted
March 28, 2011
Study Start
November 1, 2002
Primary Completion
December 1, 2005
Study Completion
May 1, 2006
Last Updated
March 28, 2011
Record last verified: 2003-11