MRI Assessment of Pulmonary Edema in Acute Heart Failure

NCT ID: NCT03999138

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2026-06-01

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.

Detailed Description

Heart failure is a condition where the heart is unable to pump enough blood to meet the body's needs and Acute Heart Failure is a sudden worsening of this condition. It is associated with many symptoms but most commonly includes shortness of breath due to pulmonary edema (or increased "lung water").

A physical exam and chest x-ray are commonly used to diagnose AHF and estimate the amount of increased lung water in patients with AHF. This study will use images from MRI (Magnetic Resonance Imaging) scans to obtain a more accurate measurement of the increased lung water in AHF patients. Lung water will be measured via MRI at hospital admission and discharge to find out the change in lung water over the course of hospitalization and treatment. The investigators will collect NT-proBNP and perform a chest x-ray upon hospital admission and again upon discharge, if not already done as part of usual care. The investigators will follow medical records for up to 5 years after hospitalization to see if the accurate lung water measurements obtained in hospital can predict long term outcomes. This is a multi-centre project and a total of 300 patients will be recruited to participate.

Conditions

Acute Heart Failure; Pulmonary Edema With Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Arm

MRI

Intervention Type: 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.

Interventions

MRI

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: ACTIVE_NOT_RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ian Paterson, MD

Role: CONTACT

DPaterson@ottawaheart.ca

613-696-7267

Poppy MacPhee, RN, BScN

Role: CONTACT

pmacphee@ottawaheart.ca

613-696-7000 ext. 14646

Facility Contacts

Ian Paterson, MD

Role: primary

dpaterson@ottawaheart.ca

Other Identifiers

Pro00091033

Identifier Type: -

Identifier Source: org_study_id