Back to resultsEvaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure, Congestive focused on measuring lung water measures, pulmonary edema, MRI, heart failure
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Healthy Volunteer
Heart Failure
Arm Description
Healthy Volunteer cohort
Heart Failure cohort
Outcomes
Primary Outcome Measures
Lung water distribution as measured by MRI
MRI test
Lung water concentration as measured by MRI
MRI test
Secondary Outcome Measures
Between patient variability in lung water concentration as measured by MRI at 2 independent visits
MRI test
Within patient variability in lung water concentration as measured by MRI at 2 independent visits
MRI test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01277679
Brief Title
Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
lung water measures, pulmonary edema, MRI, heart failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteer
Arm Type
Other
Arm Description
Healthy Volunteer cohort
Arm Title
Heart Failure
Arm Type
Other
Arm Description
Heart Failure cohort
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
Primary Outcome Measure Information:
Title
Lung water distribution as measured by MRI
Description
MRI test
Time Frame
Visit 1 and Visit 2 will be approximately 1 week apart
Title
Lung water concentration as measured by MRI
Description
MRI test
Time Frame
Visit 1 and Visit 2 will be approximately 1 week apart
Secondary Outcome Measure Information:
Title
Between patient variability in lung water concentration as measured by MRI at 2 independent visits
Description
MRI test
Time Frame
Visit 1 and Visit 2 will be approximately 1 week apart
Title
Within patient variability in lung water concentration as measured by MRI at 2 independent visits
Description
MRI test
Time Frame
Visit 1 and Visit 2 will be approximately 1 week apart
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
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