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Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277679
First received: November 18, 2010
Last updated: March 15, 2012
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
 Procedure: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Lung water distribution as measured by MRI [ Time Frame: Visit 1 and Visit 2 will be approximately 1 week apart ] [ Designated as safety issue: No ]
    MRI test

  • Lung water concentration as measured by MRI [ Time Frame: Visit 1 and Visit 2 will be approximately 1 week apart ] [ Designated as safety issue: No ]
    MRI test


Secondary Outcome Measures:
  • Between patient variability in lung water concentration as measured by MRI at 2 independent visits [ Time Frame: Visit 1 and Visit 2 will be approximately 1 week apart ] [ Designated as safety issue: No ]
    MRI test

  • Within patient variability in lung water concentration as measured by MRI at 2 independent visits [ Time Frame: Visit 1 and Visit 2 will be approximately 1 week apart ] [ Designated as safety issue: No ]
    MRI test


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy Volunteer
Healthy Volunteer cohort
 Procedure: MRI
MRI of lungs to measure lung water content before and after passive leg raising (PLR)
Heart Failure
Heart Failure cohort
 Procedure: MRI
MRI of lungs to measure lung water content before and after passive leg raising (PLR)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study intends to recruit enough subjects to yield up to 15 evaluable datasets in each of two groups of subjects: those with heart failure and healthy volunteers.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277679

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, W12 0HS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01277679     History of Changes
Other Study ID Numbers: 114747
Study First Received: November 18, 2010
Last Updated: March 15, 2012
Health Authority: United Kingdom: National Research Ethics Service (NRES)

Keywords provided by GlaxoSmithKline:
lung water measures
pulmonary edema
MRI
heart failure

Additional relevant MeSH terms:
Heart Failure
Pulmonary Edema
Heart Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013