New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)

Last updated: October 21, 2020
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

1

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04600115
IRB 94980
R01HL135328
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study's main specific aims are;

  1. To develop robust acquisition and reconstruction methods specifically for the study of microvascular cardiac remodeling with MRI which will include very innovative quantitative perfusion methods, as well as fibrosis quantification, longitudinal strain, and phase contrast imaging for flow.

  2. Test the new methods for identifying the clinical task of characterizing HFpEF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All participants will be over the age of 18 and able to provide consent

  • Group A (volunteers, with or without cardiac disease): Volunteers will beavailable for at least one study visit

  • Group B (HFpEF patient volunteers): Volunteers will have a diagnosis of HFpEF andbe safe to be imaged with MRI

Exclusion

Exclusion Criteria:

  • minors

  • Critically ill patients, patients on ventilators, patients with unstable angina orwith hypotension, asthmatics, and other patients whose medical care or safety may beat risk from undergoing an MRI examination will be excluded.

  • Patients with claustrophobia will also be excluded from the study if this cannot becontrolled with standard methods (valium or benadryl).

  • Patients with contraindication to MRI (metal implants, or certain types of heartvalves),

  • pregnant patients, , mentally disabled patients and prisoners will be excluded fromthis study. (All criteria apply to patients and normal volunteers).

  • Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidneyfunction (GFR<30) excluded from the study due to the (very small) risk associated withgadolinium contrast agents.

  • This threshold may be modified, depending on practices determined by the RadiologyDepartment and the IRB.

  • Patients with a known allergy or contraindication to Adenosine and/or Regadenoson willbe excluded from stress MRI cohorts.

  • All participants that will receive a stress agent will refrain from consuming caffeinefor at least 12 hours prior to each MRI

  • Subjects with a known contraindication to Adenosine and/or Regadenoson will only beenrolled in scans where no stress agent will be administered

Study Design

Total Participants: 100
Study Start date:
March 03, 2017
Estimated Completion Date:
March 03, 2023

Study Description

Heart failure with preserved ejection fraction (HFpEF) is currently being studied intensely as several large trials of drug therapies have failed to benefit patients. Better characterization of these patients is important, and there are open questions regarding microvascular disease and remodeling in the HFpEF population. New MRI methods could be ideal to better characterize and understand HFpEF and its response to treatments. This project seeks to develop, evaluate and apply new MRI methods for high-end perfusion imaging. These methods will estimate endo/epi ratios across the cardiac cycle in free-breathing studies, which will provide new information about microvascular disease. This is of particular value for assessing HFpEF.

The idea of this project is to combine new techniques for quantitative cardiac perfusion MRI imaging that would be ideally suited for answering open questions regarding HFpEF and for studying microvascular disease. The methods could potentially also predict patients who might respond to particular drug therapies.

The new techniques include "simultaneous multi-slice" imaging which has not been used this way for myocardial perfusion imaging. In particular, we are developing an innovative hybrid of the standard saturation pulse and steady state spoiled gradient echo acquisitions. We also are developing a new method for using 3D "stack of stars" + 2D slice in the same scan for arterial input function assessment to quantify perfusion, and new methods for measuring T1.

Connect with a study center

  • university of Utah, Radiology Research

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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