Heart FailurePhase 1NCT02364752
A Study Evaluating Biomarkers in Participants With Heart Failure (MK-0000-344)
A Phase 1 study testing Blood Draw and Loop Diuretic Withdrawal/Salt Load in people with Heart Failure, run by Merck Sharp & Dohme LLC.
Trial summary
The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels in healthy participants and participants with cardiac dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Blood Draw and Loop Diuretic Withdrawal/Salt Load
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female of reproductive potential must demonstrate non-pregnant state, and agree to use two acceptable methods of birth control
- postmenopausal or surgically sterile female
- have a Body Mass Index (BMI) >= 18 and =< 35 kg/m^2, inclusive
- healthy participants are in general good health
- participants with HF have no untreated, significant health issue from other co-morbidities, e.g. uncontrolled hypertension
- is willing to undergo echocardiography, CMR, and other study assessments
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- participants with HF have a diagnosis of cardiomyopathy, and slight to moderate limitation of physical activity, but are comfortable at rest
- participants with HF are on a stable medical therapy for HF for two weeks prior to start of Part 1
- participants with HF are on a stable diuretic regimen of >= 40 mg/day furosemide or >= 10 mg/day torsemide for at least 2 weeks prior to start of Part 1
Who cannot join
- has any clinically significant, uncontrolled renal, endocrine (except Type II Diabetes), neurological, hepatic, immunological or inflammatory disease
- has a history of cancer (malignancy)
- had major surgery or donated/lost approximately 500 mL of blood within 4 weeks prior to screening
- participated in another investigational trial within 4 weeks prior to screening
- excepting permitted medications, uses prescription, or non-prescription drugs or herbal remedies 2 weeks prior to enrollment until completion of trial
- takes medications that affect BNP levels within 30 days prior to screening
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- undergoes high-intensity physical exercise from 1 week prior to pretrial visit until completion of trial
- has implanted or embedded metal objects in body that in response to a magnetic field could cause injury
- suffers from claustrophobia making them unable to undergo CMR scanning
- consumes alcohol for 7 days prior to screening until completion of study
- consumes excessive amounts of caffeinated beverages
- uses cannabis regularly, or any illicit drugs, or has a history of drug (including alcohol) abuse within prior 12 months
About this study
Official title: A Clinical Trial to Evaluate Circulating and Imaging Biomarkers in Heart Failure Patients
The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and other circulating biomarker levels, and performs imaging in participants with cardiac dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy participants, biomarker levels are elevated in participants with mild/moderate and severe cardiac dysfunction.
- Conditions
- Heart Failure
- Being tested
- Blood Draw, Loop Diuretic Withdrawal/Salt Load
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Loop Diuretic Withdrawal/Salt LoadProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Part 1: Blood is obtained from healthy participants on 3 consecutive days, and participants undergo Cardiac Magnetic Resonance Imaging (CMR) and two-dimensional speckle tracking echocardiography (2DSTE) on one of those 3 days. Receives: Procedure: Blood Draw |
| Mild/moderate heart failure (HF) | Experimental | Part 1: Blood is obtained from participants with mild/moderate HF on 3 consecutive days, and participants undergo CMR and 2DSTE on one of those 3 days. Part 2: Within 5 days of completing Part 1 participants have a 24 hour loop diuretic withdrawal, and 15 hour 0.9% normal saline infusion; followed by a blood draw, CMR and 2DSTE. Receives: Procedure: Blood Draw; Procedure: Loop Diuretic Withdrawal/Salt Load |
| Severe HF | Experimental | Part 1: Blood is obtained from participants with severe HF on 3 consecutive days, and participants undergo CMR and 2DSTE on one of those 3 days. Part 2: Within 5 days of completing Part 1 participants have a 24 hour loop diuretic withdrawal, and 15 hour 0.9% normal saline infusion; followed by a blood draw, CMR and 2DSTE. Receives: Procedure: Blood Draw; Procedure: Loop Diuretic Withdrawal/Salt Load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of total BNP in Part 1
Measured: Up to Day 3
Level of total BNP in Part 2
Measured: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
Secondary outcomes (4)
Level of active BNP in Part 1
Measured: Up to Day 3
Level of active BNP in Part 2
Measured: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
Ratio of total BNP/active BNP in Part 1
Measured: Up to Day 3
Ratio of total BNP/active BNP in Part 2
Measured: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364752
- Sponsor's protocol ID
- 0000-344
- Status last verified
- Mar 2016
- First submitted
- 10 Feb 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Circulating and Imaging Biomarkers in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02364752
- Acronym / sponsor ID
- 0000-344
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and other circulating biomarker levels, and performs imaging in participants with cardiac dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy participants, biomarker levels are elevated in participants with mild/moderate and severe cardiac dysfunction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Procedure: Blood DrawPart 1: Blood is obtained from healthy participants on 3 consecutive days, and participants undergo Cardiac Magnetic Resonance Imaging (CMR) and two-dimensional speckle tracking echocardiography (2DSTE) on one of those 3 days. |
| Mild/moderate heart failure (HF) | Experimental | Procedure: Blood Draw, Procedure: Loop Diuretic Withdrawal/Salt LoadPart 1: Blood is obtained from participants with mild/moderate HF on 3 consecutive days, and participants undergo CMR and 2DSTE on one of those 3 days. Part 2: Within 5 days of completing Part 1 participants have a 24 hour loop diuretic withdrawal, and 15 hour 0.9% normal saline infusion; followed by a blood draw, CMR and 2DSTE. |
| Severe HF | Experimental | Procedure: Blood Draw, Procedure: Loop Diuretic Withdrawal/Salt LoadPart 1: Blood is obtained from participants with severe HF on 3 consecutive days, and participants undergo CMR and 2DSTE on one of those 3 days. Part 2: Within 5 days of completing Part 1 participants have a 24 hour loop diuretic withdrawal, and 15 hour 0.9% normal saline infusion; followed by a blood draw, CMR and 2DSTE. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- female of reproductive potential must demonstrate non-pregnant state, and agree to use two acceptable methods of birth control
- postmenopausal or surgically sterile female
- have a Body Mass Index (BMI) >= 18 and =< 35 kg/m^2, inclusive
- healthy participants are in general good health
- participants with HF have no untreated, significant health issue from other co-morbidities, e.g. uncontrolled hypertension
Key exclusion criteria (12 listed)
- has any clinically significant, uncontrolled renal, endocrine (except Type II Diabetes), neurological, hepatic, immunological or inflammatory disease
- has a history of cancer (malignancy)
- had major surgery or donated/lost approximately 500 mL of blood within 4 weeks prior to screening
- participated in another investigational trial within 4 weeks prior to screening
- excepting permitted medications, uses prescription, or non-prescription drugs or herbal remedies 2 weeks prior to enrollment until completion of trial
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 |
|---|---|---|
| Blood Draw | Procedure or surgery | Healthy, Mild/moderate heart failure (HF), Severe HF |
| Loop Diuretic Withdrawal/Salt Load | Procedure or surgery | Mild/moderate heart failure (HF), Severe HF |
Primary outcome
Level of total BNP in Part 1
Time frame: Up to Day 3
Level of total BNP in Part 2
Time frame: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
4 secondary outcomes
Level of active BNP in Part 1
Time frame: Up to Day 3
Level of active BNP in Part 2
Time frame: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
Ratio of total BNP/active BNP in Part 1
Time frame: Up to Day 3
Ratio of total BNP/active BNP in Part 2
Time frame: Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood Draw and Loop Diuretic Withdrawal/Salt Load in people with Heart Failure, run by Merck Sharp & Dohme LLC.
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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Level of total BNP in Part 1 (time frame: Up to Day 3). 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?
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 11 Mar 2016.