Diagnosing Natriuretic Peptide Deficiency
- Registration Number
- NCT03035929
- Lead Sponsor
- Vanderbilt University Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy Dexamethasone 10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions.
- Primary Outcome Measures
Name Time Method Changes in NT-proANP From Baseline to 8 Hours baseline and 8 hours Change in natriuretic peptide levels after drug administration
Changes in NT-proBNP From Baseline to 8 Hours Baseline and 8 hours Change in natriuretic peptide levels after drug administration
- Secondary Outcome Measures
Name Time Method Changes in NT-proANP baseline, 24 hours, 48 hours and 72 hours Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Changes in NT-proBNP at baseline, 24 hours, 48 hours and 72 hours Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
BNP (B-type Natriuretic Peptide) 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration Natriuretic peptide levels after drug administration
ANP (Atrial Natriuretic Peptide) 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration Natriuretic peptide levels after drug administration
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States