Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnosing Natriuretic Peptide Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035929
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine N. Bachmann, MD, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 30, 2017
Results First Submitted Date  ICMJE August 20, 2018
Results First Posted Date  ICMJE June 20, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date June 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Changes in NT-proANP [ Time Frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration ]
    Change in natriuretic peptide levels after drug administration
  • Changes in NT-proBNP [ Time Frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration ]
    Change in natriuretic peptide levels after drug administration
Change History Complete list of historical versions of study NCT03035929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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
  • 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
  • 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
  • ANP (Atrial Natriuretic Peptide) [ Time Frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration ]
    Natriuretic peptide levels after drug administration
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • ANP (Atrial Natriuretic Peptide) [ Time Frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration ]
    Natriuretic peptide levels after drug administration
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnosing Natriuretic Peptide Deficiency
Official Title  ICMJE Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Healthy
  • Lean
Intervention  ICMJE Drug: Dexamethasone
A single dose of dexamethasone IV 4 mg will be administered.
Other Name: Dexamethasone IV
Study Arms  ICMJE Experimental: Healthy

10 Healthy subjects will undergo study procedures at four study visits.

All subjects will undergo the same procedures and interventions.

Intervention: Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2018
Actual Primary Completion Date June 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035929
Other Study ID Numbers  ICMJE 161482
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Katherine N. Bachmann, MD, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katherine N Bachmann, MD Vanderbilt Endocrinology
PRS Account Vanderbilt University Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP