Trial Outcomes & Findings for Diagnosing Natriuretic Peptide Deficiency (NCT NCT03035929)

Results Overview

Change in natriuretic peptide levels after drug administration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

baseline and 8 hours

Results posted on

2019-06-20

Participant Flow

1 participant withdrew after consent but before the baseline visit and is not included in the results.

Participant milestones

Participant milestones
Measure	Healthy 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diagnosing Natriuretic Peptide Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy n=10 Participants 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.
Age, Continuous	27.5 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 hours

Change in natriuretic peptide levels after drug administration

Outcome measures

Outcome measures
Measure	Healthy n=10 Participants 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.
Changes in NT-proANP From Baseline to 8 Hours	-0.33 nmol/l Standard Deviation 0.25

PRIMARY outcome

Timeframe: Baseline and 8 hours

Change in natriuretic peptide levels after drug administration

Outcome measures

Outcome measures
Measure	Healthy n=10 Participants 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.
Changes in NT-proBNP From Baseline to 8 Hours	18.4 pg/ml Standard Deviation 20.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Healthy n=10 Participants 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.
Changes in NT-proANP Change from baseline to 24 hours	-0.23 nmol/l Standard Deviation .22
Changes in NT-proANP Change from baseline to 48 hours	0.17 nmol/l Standard Deviation .36
Changes in NT-proANP Change from baseline to 72 hours	-0.05 nmol/l Standard Deviation .33

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Healthy n=10 Participants 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.
Changes in NT-proBNP Change from baseline to 24 hours	-5.0 pg/ml Standard Deviation 26.9
Changes in NT-proBNP Change from baseline to 48 hours	-23.4 pg/ml Standard Deviation 41.4
Changes in NT-proBNP Change from baseline to 72 hours	-16.9 pg/ml Standard Deviation 39.6

SECONDARY outcome

Timeframe: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Population: Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.

Natriuretic peptide levels after drug administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Population: Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.

Natriuretic peptide levels after drug administration

Outcome measures

Outcome data not reported

Adverse Events

Healthy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy n=10 participants at risk 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.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • 48 hours

Additional Information

Grace Henderson, Study Coordinator

Vanderbilt University Medical Center

Phone: 615-936-5356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place