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

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277679
• Other study ID #: 114747
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2010
• Last updated: May 29, 2014
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Research Ethics Service (NRES)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Pulmonary Edema

Intervention

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

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung water distribution as measured by MRI	MRI test	Visit 1 and Visit 2 will be approximately 1 week apart	No
Primary	Lung water concentration as measured by MRI	MRI test	Visit 1 and Visit 2 will be approximately 1 week apart	No
Secondary	Between patient variability in lung water concentration as measured by MRI at 2 independent visits	MRI test	Visit 1 and Visit 2 will be approximately 1 week apart	No
Secondary	Within patient variability in lung water concentration as measured by MRI at 2 independent visits	MRI test	Visit 1 and Visit 2 will be approximately 1 week apart	No