MRI Assessment of Pulmonary Edema in Acute Heart Failure

NCT03999138 | Recruiting

• 1 other identifier: Pro00091033
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Heart Failure; Pulmonary Edema With Heart Failure

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline (hospital admission)

• 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.

  7 days

• 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

  Up to 5 years

• 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

  Up to 5 years

Study Arms (1)

Single Arm

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

MRI 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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with a diagnosis of acute heart failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, Canada

ACTIVE NOT RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

RECRUITING

Central Study Contacts

Ian Paterson, MD

CONTACT

613-696-7267; DPaterson@ottawaheart.ca

Poppy MacPhee, RN, BScN

CONTACT

613-696-7000; pmacphee@ottawaheart.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 26, 2019
• Study Start: January 2, 2019
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)