NCT03035929

Diagnosing Natriuretic Peptide Deficiency

Diagnosing Natriuretic Peptide Deficiency: A Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In this pilot study, the investigators will determine the response of the natriuretic peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The goal of the proposed project is to generate preliminary data that will be used to develop power calculations, inform cutoff ranges, and inform the timing of the NP response for larger subsequent studies. Aim: To determine the range of distribution and time course of natriuretic peptide (NP) responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals. Hypothesis: Determination of the NP responses (the range and time course of changes in NP levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency of blood sampling in a definitive prospective study, as well as enable investigators to perform a sample size calculation for a definitive prospective study.

Detailed description

see above

Conditions

• Healthy
• Lean

Interventions

Type	Name	Description
DRUG	Dexamethasone	A single dose of dexamethasone IV 4 mg will be administered.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-06-08
• Completion: 2018-01-01
• First posted: 2017-01-30
• Last updated: 2019-06-20
• Results posted: 2019-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study