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: May 29, 2014
Last verified: May 2014
  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 Phase
Heart Failure, Congestive
Procedure: MRI
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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:


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)
Arms 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 29, 2014
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 September 18, 2014