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Completed

NCT Number: NCT01324245

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

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.

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Key information

Conditions

Salt-sensitive Hypertension

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers
  • Healthy
  • Normal Blood Pressure

Exclusion criteria

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

Treatment and study plan

Fenoldopam

Drug

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

Other names: Enalaprilat, Corlopam

Primary outcomes

  1. 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.

Secondary outcomes

  1. Renal Plasma Flow

    Time frame: During 3 hour fenoldopam infusion

    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

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • University of Virginia

Registry information

Official study title

Paracrine Regulation of Renal Function by Dopamine in Normotensive Humans

Acronym: Salt

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Mar 28, 2011
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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