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Completed

NCT Number: NCT03035929

Diagnosing Natriuretic Peptide Deficiency

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.

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Key information

Conditions

Healthy Lean

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

see above

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ages 18-50 years
  • BMI 18.5 to <25 kg/m^2

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

Treatment and study plan

Dexamethasone

Drug

A single dose of dexamethasone IV 4 mg will be administered.

Other names: Dexamethasone IV

Primary outcomes

  1. Changes in NT-proANP From Baseline to 8 Hours

    Time frame: baseline and 8 hours

    Change in natriuretic peptide levels after drug administration

  2. 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

  1. Changes in NT-proANP

    Time frame: 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

  2. Changes in NT-proBNP

    Time frame: 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

  3. BNP (B-type Natriuretic Peptide)

    Time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

    Natriuretic peptide levels after drug administration

  4. ANP (Atrial Natriuretic Peptide)

    Time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

    Natriuretic peptide levels after drug administration

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Diagnosing Natriuretic Peptide Deficiency: A Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 30, 2017
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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