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

March 25, 2011 updated by: Georgetown University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteers
  • Healthy
  • Normal Blood Pressure

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enalapril
2.5 mg every 12 hours for two doses
Drug: Fenoldopam
Intravenous infusion at 0.5 mics/Kg/min for three hours
Other Names:
  • Enalaprilat
  • Corlopam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the trial: a 3 hour fenoldopam infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During 3 hour fenoldopam infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

University of Virginia

Investigators

  • Principal Investigator: Aruna R Natarajan, MD, PhD, Georgetown University Hospital
  • Study Director: Pedro A Jose, MD, PhD, Georgetown University/ George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Estimate)

March 28, 2011

Last Update Submitted That Met QC Criteria

March 25, 2011

Last Verified

November 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-142
  • RR 17613 (Other Identifier: National Center for Research resources, NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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