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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Healthy
Lean
Intervention Drug: Dexamethasone
Enrollment 10
Recruitment Details  
Pre-assignment Details 1 participant withdrew after consent but before the baseline visit and is not included in the results.
Arm/Group Title Healthy
Hide Arm/Group Description

Healthy subjects will be enrolled and each will undergo study procedures at four study visits.

All subjects will undergo the same procedures and interventions.

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

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Healthy
Hide Arm/Group Description

Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants
27.5
(24.5 to 29.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
10
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  20.0%
White
7
  70.0%
More than one race
1
  10.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Changes in NT-proANP From Baseline to 8 Hours
Hide Description Change in natriuretic peptide levels after drug administration
Time Frame baseline and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy
Hide Arm/Group Description:

Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: nmol/l
-0.33  (0.25)
2.Primary Outcome
Title Changes in NT-proBNP From Baseline to 8 Hours
Hide Description Change in natriuretic peptide levels after drug administration
Time Frame Baseline and 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy
Hide Arm/Group Description:

Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: pg/ml
18.4  (20.3)
3.Secondary Outcome
Title Changes in NT-proANP
Hide Description Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Time Frame baseline, 24 hours, 48 hours and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy
Hide Arm/Group Description:

Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: nmol/l
Change from baseline to 24 hours -0.23  (.22)
Change from baseline to 48 hours 0.17  (.36)
Change from baseline to 72 hours -0.05  (.33)
4.Secondary Outcome
Title Changes in NT-proBNP
Hide Description Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Time Frame at baseline, 24 hours, 48 hours and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy
Hide Arm/Group Description:

Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: pg/ml
Change from baseline to 24 hours -5.0  (26.9)
Change from baseline to 48 hours -23.4  (41.4)
Change from baseline to 72 hours -16.9  (39.6)
5.Secondary Outcome
Title BNP (B-type Natriuretic Peptide)
Hide Description Natriuretic peptide levels after drug administration
Time Frame 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.
Arm/Group Title Healthy
Hide Arm/Group Description:

Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title ANP (Atrial Natriuretic Peptide)
Hide Description Natriuretic peptide levels after drug administration
Time Frame 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.
Arm/Group Title Healthy
Hide Arm/Group Description:

10 Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits.

All subjects will undergo the same procedures and interventions.

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 48 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy
Hide Arm/Group Description

Healthy subjects will be enrolled and each will undergo study procedures at three study visits.

All subjects will undergo the same procedures and interventions.

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

All-Cause Mortality
Healthy
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Healthy
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Gastrointestinal disorders   
Nausea  1  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grace Henderson, Study Coordinator
Organization: Vanderbilt University Medical Center
Phone: 615-936-5356
EMail: grace.henderson@vumc.org
Layout table for additonal information
Responsible Party: Katherine N. Bachmann, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03035929     History of Changes
Other Study ID Numbers: 161482
First Submitted: January 25, 2017
First Posted: January 30, 2017
Results First Submitted: August 20, 2018
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019