Diagnosing Natriuretic Peptide Deficiency

Diagnosing Natriuretic Peptide Deficiency: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Lean
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy; 10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions.	Drug: Dexamethasone; A single dose of dexamethasone IV 4 mg will be administered.; Other Names: Dexamethasone IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in NT-proANP From Baseline to 8 Hours	Change in natriuretic peptide levels after drug administration	baseline and 8 hours
Changes in NT-proBNP From Baseline to 8 Hours	Change in natriuretic peptide levels after drug administration	Baseline and 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in NT-proANP	Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours	baseline, 24 hours, 48 hours and 72 hours
Changes in NT-proBNP	Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours	at baseline, 24 hours, 48 hours and 72 hours
BNP (B-type Natriuretic Peptide)	Natriuretic peptide levels after drug administration	0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
ANP (Atrial Natriuretic Peptide)	Natriuretic peptide levels after drug administration	0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Katherine N Bachmann, MD, Vanderbilt Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 161482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No