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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
10 Healthy subjects will undergo study procedures at four study visits.
All subjects will undergo the same procedures and interventions.
A single dose of dexamethasone IV 4 mg will be administered.
Other Name: Dexamethasone IV
- 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
- 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
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
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Katherine N Bachmann, MD||Vanderbilt Endocrinology|