Last updated: 11/03/2018 17:14:50
Evaluation of MRI measures of lung water with posture changes in healthy volunteers and in patients with cardiac failure
GSK study ID
114747
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Lung water distribution as measured by MRI
Timeframe: Visit 1 and Visit 2 will be approximately 1 week apart
Lung water concentration as measured by MRI
Timeframe: Visit 1 and Visit 2 will be approximately 1 week apart
Secondary outcomes:
Between patient variability in lung water concentration as measured by MRI at 2 independent visits
Timeframe: 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
Timeframe: Visit 1 and Visit 2 will be approximately 1 week apart
Interventions:
Enrollment:
20
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Heart failure, Congestive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2011 to August 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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
- Heart Failure Patients
- History of primary pulmonary disease requiring current medication or other therapy.
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-03-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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