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RecruitingNCT04600115Updated Jul 7, 2026

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

An Early Phase 1 interventional study of Adenosine and Regadenoson in MRI Scans, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Utah · Early Phase 1, Interventional, and Health services research

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Mar 2017, registered Oct 2020).
  • Started Mar 2017; still recruiting 9 years 7 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.
Read the detailed 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.

02

Conditions studied

  • MRI Scans
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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 be available for at least one study visit
    • Group B (HFpEF patient volunteers): Volunteers will have a diagnosis of HFpEF and be safe to be imaged with MRI

Exclusion criteria

Exclusion Criteria:

  • minors
  • Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.
  • Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).
  • Patients with contraindication to MRI (metal implants, or certain types of heart valves),
  • pregnant patients, , mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).
  • Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR\<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents.
  • This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.
  • Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress MRI cohorts.
  • All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each MRI
  • Subjects with a known contraindication to Adenosine and/or Regadenoson will only be enrolled in scans where no stress agent will be administered
05

Study design

Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    MRI vs.PET with/without Cardiac disease

    Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging

    Drug: Adenosine · Drug: Regadenoson · Drug: O-15 labeled radioactive water · Device: MRI · Device: PET Imaging

Interventions

  • DrugAdenosine

    Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion

    Also known as: Adenoscan, Adenocard

  • DrugRegadenoson

    0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.

    Also known as: Lexiscan

  • DrugO-15 labeled radioactive water

    O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging

    Also known as: O-15 water

  • DeviceMRI

    Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson

  • DevicePET Imaging

    Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day

    Also known as: Positron Emission Tomography Imaging

06

What researchers measure

Primary outcomes

  1. Myocardial perfusion measured with MRI

    Myocardial perfusion measured with Magnetic Resonance Imaging (MRI) at rest and vasodilation

    Time frame: Time in the scanner to be 60-90 minutes.

Secondary outcomes

  1. ECV measures

    Extracellular volume (ECV) measures from T1 mapping pre- and post-contrast

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04600115
Lead sponsor
University of Utah
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Edward DiBella (Principal Investigator, University of Utah) — Principal investigator
First posted
Oct 23, 2020
Start date
Mar 3, 2017
Primary completion
Mar 3, 2027 (estimated)
Completion
Mar 3, 2027 (estimated)
Last update
Jul 7, 2026

Study contacts

Olivia Pratt, BS
Contact
u0447662@umail.utah.edu
801-585-6142
Collin Arsenault, BS.
Contact
collin.arsenault@hsc.utah.edu
801-587-8638
Edward DiBella, Ph.D.
principal investigator · Faculty

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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