- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999138
MRI Assessment of Pulmonary Edema in Acute Heart Failure (MAP-AHF)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ian Paterson, MD
- Phone Number: 613-696-7267
- Email: DPaterson@ottawaheart.ca
Study Contact Backup
- Name: Poppy MacPhee, RN, BScN
- Phone Number: 14646 613-696-7000
- Email: pmacphee@ottawaheart.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada
- Active, not recruiting
- University of Alberta
-
-
Ontario
-
Ottawa, Ontario, Canada
- Recruiting
- University of Ottawa Heart Institute
-
Contact:
- Ian Paterson, MD
- Email: dpaterson@ottawaheart.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single Arm
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnitude of lung water density measured with MRI at Hospital Admission
Time Frame: Baseline (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
Time Frame: 7 days
|
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)
Time Frame: Up to 5 years
|
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)
Time Frame: Up to 5 years
|
Clinical events include cardiovascular hospitalization, cardiovascular emergency
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00091033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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