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Diagnosing Natriuretic Peptide Deficiency

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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

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.


Condition or disease Intervention/treatment Phase
Healthy Lean Drug: Dexamethasone Phase 1

Detailed Description:
see above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


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 Name: Dexamethasone IV




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035929


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Katherine N Bachmann, MD Vanderbilt Endocrinology
  Study Documents (Full-Text)

Documents provided by Katherine N. Bachmann, MD, Vanderbilt University Medical Center:

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Responsible Party: Katherine N. Bachmann, MD, Instructor in Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03035929     History of Changes
Other Study ID Numbers: 161482
First Posted: January 30, 2017    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action