Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet
Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Salt-sensitive Hypertension
Intervention: Fenoldopam (Drug)
Phase: N/A
Status: Completed
Sponsored by: Georgetown University Official(s) and/or principal investigator(s): Aruna R Natarajan, MD, PhD, Principal Investigator, Affiliation: Georgetown University Hospital Pedro A Jose, MD, PhD, Study Director, Affiliation: Georgetown University/ George Washington University
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.
Clinical Details
Official title: Paracrine Regulation of Renal Function by Dopamine in Normotensive Humans
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Urinary sodium excretion
Secondary outcome: Renal Plasma Flow
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Volunteers
- Healthy
- Normal Blood Pressure
Exclusion Criteria:
- Renal Impairment
- Obesity
- Salt sensitive increase in blood pressure
Locations and Contacts
Georgetown University Medical Center, Washington, District of Columbia 20007, United States
Additional Information
Starting date: November 2002
Last updated: March 25, 2011
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