Heart Failure, Congestive Clinical Trial
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
Verified date | May 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Research Ethics Service (NRES) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | GSK Investigational Site | London |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lung water distribution as measured by MRI | MRI test | Visit 1 and Visit 2 will be approximately 1 week apart | No |
Primary | Lung water concentration as measured by MRI | MRI test | Visit 1 and Visit 2 will be approximately 1 week apart | No |
Secondary | Between patient variability in lung water concentration as measured by MRI at 2 independent visits | MRI test | Visit 1 and Visit 2 will be approximately 1 week apart | No |
Secondary | Within patient variability in lung water concentration as measured by MRI at 2 independent visits | MRI test | Visit 1 and Visit 2 will be approximately 1 week apart | No |
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