Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJune 2, 2014
May 1, 2014
7 months
November 18, 2010
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lung water distribution as measured by MRI
MRI test
Visit 1 and Visit 2 will be approximately 1 week apart
Lung water concentration as measured by MRI
MRI test
Visit 1 and Visit 2 will be approximately 1 week apart
Secondary Outcomes (2)
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
Study Arms (2)
Healthy Volunteer
OTHERHealthy Volunteer cohort
Heart Failure
OTHERHeart Failure cohort
Interventions
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2010
First Posted
January 17, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
June 2, 2014
Record last verified: 2014-05