Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes in NT-proANP From Baseline to 8 Hours
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Significant use of systemically-absorbed glucocorticoids currently or for an extended period of time during the prior 6 months
- •Current use of antihypertensive medications
- •Current use of metformin, or any antidiabetic medications (which could affect glucose and insulin levels)
- •Current use of medications known to affect dexamethasone metabolism, including phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates
- •Active, clinically significant infection at time of visit
- •History of adrenal insufficiency or Cushing's syndrome
- •Prior or current cardiovascular disease, renal disease, or liver disease
- •Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose tolerance
- •Atrial fibrillation
- •Bleeding disorder or anemia
- •Elevated Liver Functions Tests > 2 times upper limit of normal
- •Estimated glomerular filtration rate < 60 ml/min
- •HbA1c > 5.7
- •Abnormal sodium or potassium level
- •Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding
Arms & Interventions
Healthy
10 Healthy subjects will undergo study procedures at four study visits.
All subjects will undergo the same procedures and interventions.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Changes in NT-proANP From Baseline to 8 Hours
Time Frame: baseline and 8 hours
Change in natriuretic peptide levels after drug administration
Changes in NT-proBNP From Baseline to 8 Hours
Time Frame: Baseline and 8 hours
Change in natriuretic peptide levels after drug administration
Secondary Outcomes
- Changes in NT-proANP(baseline, 24 hours, 48 hours and 72 hours)
- Changes in NT-proBNP(at baseline, 24 hours, 48 hours and 72 hours)
- BNP (B-type Natriuretic Peptide)(0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration)
- ANP (Atrial Natriuretic Peptide)(0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration)
Investigators
Katherine N. Bachmann, MD
Instructor in Medicine
Vanderbilt University Medical Center