Acute Heart FailureMAP-AHFNCT03999138
MRI Assessment of Pulmonary Edema in Acute Heart Failure
An observational study of Acute Heart Failure and Pulmonary Edema With Heart Failure, run by University of Alberta at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Pulmonary Edema With Heart Failure
- What is being tested?
- MRI
- How many people
- 300 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Jan 2019to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital with a diagnosis of acute heart failure
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 1 recruiting
- Active, not recruiting
University of Alberta
Edmonton, Alberta
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
Ian Paterson, MD, dpaterson@ottawaheart.ca
About this study
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.
Read the 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.
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start2 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999138
- Sponsor's protocol ID
- Pro00091033
- Acronym
- MAP-AHF
- Status last verified
- May 2026
- First submitted
- 22 May 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No