Diagnosing Natriuretic Peptide Deficiency

Healthy Clinical Trial

Official title:

Diagnosing Natriuretic Peptide Deficiency: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035929
• Other study ID #: 161482
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 1, 2018
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Lean

Intervention

Drug:
• Dexamethasone
A single dose of dexamethasone IV 4 mg will be administered.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in NT-proANP From Baseline to 8 Hours	Change in natriuretic peptide levels after drug administration	baseline and 8 hours
Primary	Changes in NT-proBNP From Baseline to 8 Hours	Change in natriuretic peptide levels after drug administration	Baseline and 8 hours
Secondary	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
Secondary	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
Secondary	BNP (B-type Natriuretic Peptide)	Natriuretic peptide levels after drug administration	0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
Secondary	ANP (Atrial Natriuretic Peptide)	Natriuretic peptide levels after drug administration	0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration