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MRI

Phase 1

Heart Failure, Congestive | Unknown | Cardiovascular |GSK plc|Last Updated: Jun 2, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

MRI · 1 trial · 1 indication

Phase 1 1
NCT01277679Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac FailureHeart Failure, Congestive
COMPLETED20 Analytics
PHASE1COMPLETED
Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
Heart Failure, CongestiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Lung water distribution as measured by MRI
Visit 1 and Visit 2 will be approximately 1 week apart

MRI test

Lung water concentration as measured by MRI
Visit 1 and Visit 2 will be approximately 1 week apart

MRI test

Secondary Endpoints

Between patient variability in lung water concentration as measured by MRI at 2 independent visits
Visit 1 and Visit 2 will be approximately 1 week apart
Within patient variability in lung water concentration as measured by MRI at 2 independent visits
Visit 1 and Visit 2 will be approximately 1 week apart
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Healthy VolunteerOTHERHealthy Volunteer cohort
Heart FailureOTHERHeart Failure cohort

Interventions

NameTypeDescription
MRIPROCEDUREMRI of lungs to measure lung water content before and after passive leg raising (PLR)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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 a...

Countries:United Kingdom
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Frequently asked questions about MRI

What is MRI used for in Heart Failure, Congestive?

MRI is an investigational imaging technique being studied for use in Heart Failure, Congestive. It is being evaluated in a Phase 1 clinical trial to measure lung water with posture changes in patients with cardiac failure and healthy volunteers. The study is completed and enrolled 20 participants in the United Kingdom.

Who makes MRI?

MRI is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research on this imaging technique for cardiovascular applications, specifically in the area of congestive heart failure.

What phase is MRI in?

MRI is in Phase 1 clinical development. It has completed one Phase 1 trial with 20 participants. The trial was a controlled study, not randomized or double-blind, and included healthy volunteers as well as patients with congestive heart failure. The study took place in the United Kingdom.

What clinical trials is MRI in?

MRI has one completed clinical trial registered as NCT01277679, titled 'Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure.' This Phase 1 study enrolled 20 participants with congestive heart failure and healthy volunteers in the United Kingdom.

Is MRI FDA approved?

MRI is not FDA approved. It is an investigational imaging technique currently in Phase 1 clinical development for congestive heart failure. The only completed trial was a small controlled study of 20 participants in the United Kingdom, and it remains in early-stage clinical research.