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

NCT ID: NCT01324245

Last Updated: 2011-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2006-05-31

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.

Conditions

Salt-sensitive Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: QUADRUPLE

Study Groups

Enalapril

2.5 mg every 12 hours for two doses

Group Type: EXPERIMENTAL

Fenoldopam

Intervention Type: DRUG

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

Interventions

Fenoldopam

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

Intervention Type: DRUG

Other Intervention Names

Enalaprilat; Corlopam

Eligibility Criteria

Inclusion Criteria

• Volunteers
• Healthy
• Normal Blood Pressure

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Georgetown University Hospital

Principal Investigators

Aruna R Natarajan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Pedro A Jose, MD, PhD

Role: STUDY_DIRECTOR

Georgetown University/ George Washington University

Locations

Georgetown University Medical Center

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

Countries

United States

Other Identifiers

RR 17613

Identifier Type: OTHER

Identifier Source: secondary_id

2003-142

Identifier Type: -

Identifier Source: org_study_id