HealthyPhase 1NCT03035929

Diagnosing Natriuretic Peptide Deficiency

A Phase 1 study testing Dexamethasone in people with Healthy and Lean, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Lean
What is being tested?: Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2017to 1 Jan 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women ages 18-50 years
BMI 18.5 to <25 kg/m^2

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Diagnosing Natriuretic Peptide Deficiency: A Pilot Study

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.

Read the detailed description

see above

Conditions: Healthy, Lean
Being tested: Dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Also called Dexamethasone IV
A single dose of dexamethasone IV 4 mg will be administered.

Study groups in NCT03035929
Study group	Role	What they receive
Healthy	Experimental	10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions. Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in NT-proANP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration
Measured: baseline and 8 hours
Changes in NT-proBNP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration
Measured: Baseline and 8 hours

Secondary outcomes (4)

Changes in NT-proANP
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Measured: baseline, 24 hours, 48 hours and 72 hours
Changes in NT-proBNP
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
Measured: at baseline, 24 hours, 48 hours and 72 hours
BNP (B-type Natriuretic Peptide)
Natriuretic peptide levels after drug administration
Measured: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration
ANP (Atrial Natriuretic Peptide)
Natriuretic peptide levels after drug administration
Measured: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20171 Jan 2018

First posted30 Jan 2017 (estimated)
Study start1 Jan 2017
Primary completion8 Jun 2017
Study completion1 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03035929
Sponsor's protocol ID: 161482
Status last verified: Mar 2019
First submitted: 25 Jan 2017
Last updated: 20 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
ClinicalTrials.gov ID: NCT03035929
Acronym / sponsor ID: 161482
Conditions: Healthy, Lean
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 8 Jun 2017 (actual)
Study completion: 1 Jan 2018 (actual)
First posted: 30 Jan 2017 (estimated)
Results: Posted 20 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

see above

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy	Experimental	Drug: Dexamethasone10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Men and women ages 18-50 years
BMI 18.5 to <25 kg/m^2

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneAlso: Dexamethasone IVA single dose of dexamethasone IV 4 mg will be administered.	Drug	Healthy

Primary outcome

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

4 secondary outcomes

Changes in NT-proANP
Time frame: baseline, 24 hours, 48 hours and 72 hours
Changes in NT-proBNP
Time frame: at baseline, 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
ANP (Atrial Natriuretic Peptide)
Time frame: 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration

Results and safety

Results posted to the registry on 20 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy	10	10

Primary outcome: Changes in NT-proANP From Baseline to 8 Hours

Time frame: baseline and 8 hours. Mean (Standard Deviation). Unit: nmol/l

Measure	Healthy n = 10
Value	-0.33 (0.25)

Primary outcome: Changes in NT-proBNP From Baseline to 8 Hours

Time frame: Baseline and 8 hours. Mean (Standard Deviation). Unit: pg/ml

Measure	Healthy n = 10
Value	18.4 (20.3)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine N Bachmann, MD principal investigator

Vanderbilt Endocrinology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexamethasone in people with Healthy and Lean, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in NT-proANP From Baseline to 8 Hours (time frame: baseline and 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03035929.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.