Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
NCT ID: NCT01277679
Last Updated: 2014-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2011-01-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Healthy Volunteer
Healthy Volunteer cohort
MRI
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
Heart Failure
Heart Failure cohort
MRI
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
Interventions
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MRI
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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114747
Identifier Type: -
Identifier Source: org_study_id
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