MAP-AHF: MRI Assessment of Pulmonary Edema in Acute Heart Failure

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT03999138
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
300
1
65
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI

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 one year after hospitalization to see if the accurate lung water measurements obtained in hospital can predict long term outcomes. This is a single-centre project and a total of 300 patients will be recruited to participate.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
MRI Assessment of Pulmonary Edema in Acute Heart Failure
Actual Study Start Date :
Jan 2, 2019
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Single Arm

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. Magnitude of lung water density measured with MRI at Hospital Admission [Baseline (hospital admission)]

    Lung water density (0-100%) is the fraction of lung tissue that contains water

  2. Difference in lung water density measured with MRI at hospital admission and hospital discharge [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.

  3. Number and timing of clinical events and their statistical association with Outcome 1 (Magnitude of lung water density measured with MRI at Hospital Admission) [Up to 5 years]

    Clinical events include cardiovascular hospitalization, cardiovascular emergency department visits or death

  4. 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) [Up to 5 years]

    Clinical events include cardiovascular hospitalization, cardiovascular emergency

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Edmonton Alberta Canada

Sponsors and Collaborators

  • University of Alberta
  • Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard Thompson, Professor, University of Alberta
ClinicalTrials.gov Identifier:
NCT03999138
Other Study ID Numbers:
  • Pro00091033
First Posted:
Jun 26, 2019
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021