Phase 1
N=10
Diagnosing Natriuretic Peptide Deficiency
Healthy · Lean
Bottom Line
View on ClinicalTrials.gov: NCT03035929 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Changes in NT-proANP From Baseline to 8 Hours — -0.33 nmol/l
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dexamethasone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in NT-proANP From Baseline to 8 Hours |
-0.33 | — |
| PRIMARY Changes in NT-proBNP From Baseline to 8 Hours |
18.4 | — |
| SECONDARY Changes in NT-proANP |
-0.23; 0.17; -0.05 | — |
| SECONDARY Changes in NT-proBNP |
-5.0; -23.4; -16.9 | — |
| SECONDARY BNP (B-type Natriuretic Peptide) |
— | — |
| SECONDARY ANP (Atrial Natriuretic Peptide) |
— | — |
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.
Eligibility Criteria
Inclusion criteria
- Men and women ages 18-50 years
- BMI 18.5 to 2 times upper limit of normal
- Estimated glomerular filtration rate 5.7
- Abnormal sodium or potassium level
- Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding
Data sourced from ClinicalTrials.gov (NCT03035929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.