Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
Phase 1
Completed
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT01277679
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Lung water distribution as measured by MRI Visit 1 and Visit 2 will be approximately 1 week apart MRI test
Lung water concentration as measured by MRI Visit 1 and Visit 2 will be approximately 1 week apart MRI test
- Secondary Outcome Measures
Name Time Method 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 MRI test
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 MRI test
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom
GSK Investigational Site🇬🇧London, United Kingdom