NCT01277679CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Lung water distribution as measured by MRI
Study Overview
Brief 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 model for the evaluation of various classes of molecules for target validation and for dose selection.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
Healthy Volunteer
Other
Healthy Volunteer cohort
Intervention: MRI (Procedure)
Heart Failure
Other
Heart Failure cohort
Intervention: MRI (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Between patient variability in lung water concentration as measured by MRI at 2 independent visits(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(Visit 1 and Visit 2 will be approximately 1 week apart)
Investigators
Study Sites (1)
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