MRI Assessment of Pulmonary Edema in Acute Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
Researchers are testing a more accurate way to measure how much fluid is in the lungs (also called pulmonary edema, or "increased lung water") in people with Heart Failure (HF) using MRI (Magnetic Resonance Imaging). There is little known about the exact level of lung water in patients with AHF or how these levels change from the time of hospital admission to discharge. The purpose of this research study is to measure the lung water in patients hospitalized for HF, to determine the change in lung water over the course of hospitalization and treatment, and to find out if lung water levels can predict if patients are higher or lower risk for returning to the hospital or dying from heart failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older and willing/able to provide informed consent
patients being treated for acute heart failure (including those patients with both reduced and preserved ejection fraction)
patients receiving medical therapy for pulmonary edema by current standard of care (including oral or IV diuretics)
patients identified within 48 hours of initiation of medical therapy for pulmonary edema, defined as the time of first diuretic (IV or PO) or escalation of existing diuretic therapy administered within the ED or hospital
Disqualifiers
contraindication to MRI
patient too critically ill/unstable as per the clinical care team for transport to MRI scanner within the required scanning window
moderate to severe dementia
Trial population
Patients admitted to hospital with a diagnosis of acute heart failure
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Diagnostic testMRI studies (non-contrast) will consist of a free-breathing localizer (\~10 seconds) followed by a free-breathing yarnball water density scan, for a total MRI time of \< 3 minutes.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Single Arm1 intervention
Trial outcomes
Primary outcomes
1
Magnitude of lung water density measured with MRI at Hospital Admission
Lung water density (0-100%) is the fraction of lung tissue that contains water
Time frame
Baseline (hospital admission)2
Difference in lung water density measured with MRI at hospital admission and hospital discharge
Absolute change in lung water density from baseline (hospital admission) to hospital discharge. Lung water density will be 0%-100% at each time point.
Time frame
7 days3
Number and timing of clinical events and their statistical association with Outcome 1 (Magnitude of lung water density measured with MRI at Hospital Admission)
Clinical events include cardiovascular hospitalization, cardiovascular emergency department visits or death
Time frame
Up to 5 years4
Number and timing of clinical events and their statistical association with Outcome 2 (Difference in lung water density measured with MRI at hospital admission and hospital discharge)
Clinical events include cardiovascular hospitalization, cardiovascular emergency
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov