Heart Failure, CongestivePhase 1NCT01277679
Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
A Phase 1 study testing MRI in people with Heart Failure, Congestive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The aim of this study is to establish a model for the evaluation of drug targets using postural measures to induce changes in lung water concentration as assessed by MRI. A reduction in the magnitude and rate of water transudation with postural changes in patients with congestive heart failure (CHF) could provide a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Aug 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Heart Failure Patients:
- Established diagnosis of mild to moderate heart failure of any aetiology with symptoms defined as corresponding to the New York Heart Association (NYHA) class I, II or III
- Able in the opinion of the patient and investigator to be supine for 1 hour and to experience passive leg raising (PLR) whilst in the MRI scanner
- Male or female over 18 years of age at the time of signing the informed consent
- Negative urine or serum pregnancy test
- Capable of giving written informed consent
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- Registered with a UK general practitioner.
- Participants must read (in English) at a level sufficient to adequately complete study related questionnaires
- Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Healthy Volunteers:
- Healthy as determined by a responsible physician
- Male or female over 18 years of age at the time of signing the informed consent
- Capable of giving written informed consent
- Negative urine or serum pregnancy test
- Registered with a UK general practitioner
- Participants must read (in English) at a level sufficient to adequately complete study related questionnaires
- Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Who cannot join
- Heart Failure Patients
- History of primary pulmonary disease requiring current medication or other therapy.
- Orthopnoea of sufficient severity to preclude supine scanning.
- Hip or leg pathology of sufficient severity to prevent extension of both legs to 45 degrees.
- Unstable heart failure, defined as change in NYHA status, change in heart failure therapy regimen or hospitalization for acute decompensation of heart failure within preceding 6 weeks.
- Unstable angina within the past 3 months
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- Current smoker, defined as having smoked in the preceding 1 year
- Uncontrolled hypertension (resting systolic BP > 160 mmHg or resting diastolic BP > 100mmHg)
- Resting hypoxia (SaO2 <93%).
- Contraindication to MRI scanning
- Pregnant females
- Positive drugs of abuse or alcohol screen.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Healthy Volunteers
- History of primary pulmonary disease requiring current medication or other therapy
- Current smoker, defined as having smoked in the preceding 1 year
- Hip or leg pathology of sufficient severity to prevent extension of both legs to 45 degrees
- Contraindication to MRI scanning
- Pregnant females
- Positive drugs of abuse or alcohol screen
- Unwillingness or inability to follow the procedures outlined in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of MRI Measures of Lung Water Increases With Postural Changes in Healthy Subjects and in Patients With Cardiac Failure: A Methods Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
The aim of this study is to establish a model for the evaluation of drug targets using postural measures to induce changes in lung water concentration as assessed by MRI. A reduction in the magnitude and rate of water transudation with postural changes in patients with congestive heart failure (CHF) could provide a model for the evaluation of various classes of molecules for target validation and for dose selection.
- Conditions
- Heart Failure, Congestive
- Being tested
- MRI
- Keywords
- lung water measures, pulmonary edema, MRI, heart failure
- Medical subject headings
- Heart Failure, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Other | Healthy Volunteer cohort Receives: Procedure: MRI |
| Heart Failure | Other | Heart Failure cohort Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung water distribution as measured by MRI
MRI test
Measured: Visit 1 and Visit 2 will be approximately 1 week apart
Lung water concentration as measured by MRI
MRI test
Measured: Visit 1 and Visit 2 will be approximately 1 week apart
Secondary outcomes (2)
Between patient variability in lung water concentration as measured by MRI at 2 independent visits
MRI test
Measured: Visit 1 and Visit 2 will be approximately 1 week apart
Within patient variability in lung water concentration as measured by MRI at 2 independent visits
MRI test
Measured: Visit 1 and Visit 2 will be approximately 1 week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277679
- Sponsor's protocol ID
- 114747
- Status last verified
- May 2014
- First submitted
- 18 Nov 2010
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of MRI Measures of Lung Water Increases With Postural Changes in Healthy Subjects and in Patients With Cardiac Failure: A Methods Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
- ClinicalTrials.gov ID
- NCT01277679
- Acronym / sponsor ID
- 114747
- Conditions
- Heart Failure, Congestive
- Keywords
- lung water measures, pulmonary edema, MRI, heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Jan 2011 (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 study is to establish a model for the evaluation of drug targets using postural measures to induce changes in lung water concentration as assessed by MRI. A reduction in the magnitude and rate of water transudation with postural changes in patients with congestive heart failure (CHF) could provide a model for the evaluation of various classes of molecules for target validation and for dose selection.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Other | Procedure: MRIHealthy Volunteer cohort |
| Heart Failure | Other | Procedure: MRIHeart Failure cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Heart Failure Patients:
- Established diagnosis of mild to moderate heart failure of any aetiology with symptoms defined as corresponding to the New York Heart Association (NYHA) class I, II or III
- Able in the opinion of the patient and investigator to be supine for 1 hour and to experience passive leg raising (PLR) whilst in the MRI scanner
- Male or female over 18 years of age at the time of signing the informed consent
- Negative urine or serum pregnancy test
Key exclusion criteria (21 listed)
- Heart Failure Patients
- History of primary pulmonary disease requiring current medication or other therapy.
- Orthopnoea of sufficient severity to preclude supine scanning.
- Hip or leg pathology of sufficient severity to prevent extension of both legs to 45 degrees.
- Unstable heart failure, defined as change in NYHA status, change in heart failure therapy regimen or hospitalization for acute decompensation of heart failure within preceding 6 weeks.
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 |
|---|---|---|
| MRIMRI of lungs to measure lung water content before and after passive leg raising (PLR) | Procedure or surgery | Healthy Volunteer, Heart Failure |
Primary outcome
Lung water distribution as measured by MRI
Time frame: Visit 1 and Visit 2 will be approximately 1 week apart
MRI test
Lung water concentration as measured by MRI
Time frame: Visit 1 and Visit 2 will be approximately 1 week apart
MRI test
2 secondary outcomes
Between patient variability in lung water concentration as measured by MRI at 2 independent visits
Time frame: Visit 1 and Visit 2 will be approximately 1 week apart
Within patient variability in lung water concentration as measured by MRI at 2 independent visits
Time frame: Visit 1 and Visit 2 will be approximately 1 week apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 MRI in people with Heart Failure, Congestive, run by GlaxoSmithKline at 1 site in United Kingdom.
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 17 inclusion and 21 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 2 Jun 2014. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung water distribution as measured by MRI (time frame: Visit 1 and Visit 2 will be approximately 1 week apart). 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 2 Jun 2014.