Recruiting

Observational Study

Sponsor:

University of Alberta

Code:

NCT03999138

Conditions

Acute Heart Failure

Pulmonary Edema With Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

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

Study ID

NCT03999138

Start date

Jan 2, 2019

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Single Arm

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.

Primary outcome measure

  • Magnitude of lung water density measured with MRI at Hospital Admission [ Time Frame: Baseline (hospital admission) ]
  • Difference in lung water density measured with MRI at hospital admission and hospital discharge [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Ian Paterson, MD

613-696-7267DPaterson@ottawaheart.ca

Poppy MacPhee, RN, BScN

613-696-7000pmacphee@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada

Contacts

Ian Paterson, MD

dpaterson@ottawaheart.ca

More Information

Sponsor

University of Alberta

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-08.