Skip to content

Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet

Paracrine Regulation of Renal Function by Dopamine in Normotensive Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01324245
Acronym
Salt
Enrollment
45
Registered
2011-03-28
Start date
2002-11-30
Completion date
2006-05-31
Last updated
2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Salt-sensitive Hypertension

Keywords

Salt, Balance, Renin Angiotensin System, Fenoldopam\blood Pressure, Sodium

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.

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.

Interventions

Intravenous infusion at 0.5 mics/Kg/min for three hours

Sponsors

University of Virginia
CollaboratorOTHER
Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Volunteers * Healthy * Normal Blood Pressure

Exclusion criteria

* Renal Impairment * Obesity * Salt sensitive increase in blood pressure

Design outcomes

Primary

MeasureTime frameDescription
Urinary sodium excretionDuring the trial: a 3 hour fenoldopam infusionAll 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.

Secondary

MeasureTime frameDescription
Renal Plasma FlowDuring 3 hour fenoldopam infusionIn 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026