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Completed

NCT Number: NCT01277679

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

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure Lung Diseases Pulmonary Edema Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, W12 0HS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

MRI of lungs to measure lung water content before and after passive leg raising (PLR)

Primary outcomes

  1. Lung water distribution as measured by MRI

    Time frame: Visit 1 and Visit 2 will be approximately 1 week apart

    MRI test

  2. Lung water concentration as measured by MRI

    Time frame: Visit 1 and Visit 2 will be approximately 1 week apart

    MRI test

Secondary outcomes

  1. 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

    MRI test

  2. 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

    MRI test

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2011
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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