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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04600115
Enrollment
100
Registered
2020-10-23
Start date
2017-03-03
Completion date
2027-03-03
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRI Scans

Brief 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.

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.

Interventions

DRUGAdenosine

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

DRUGRegadenoson

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

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

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

Sponsors

University of Utah
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Myocardial perfusion measured with MRITime in the scanner to be 60-90 minutes.Myocardial perfusion measured with Magnetic Resonance Imaging (MRI) at rest and vasodilation

Secondary

MeasureTime frameDescription
ECV measuresOne yearExtracellular volume (ECV) measures from T1 mapping pre- and post-contrast

Countries

United States

Contacts

CONTACTOlivia Pratt, BS
u0447662@umail.utah.edu801-585-6142
CONTACTCollin Arsenault, BS.
collin.arsenault@hsc.utah.edu801-587-8638
PRINCIPAL_INVESTIGATOREdward DiBella, Ph.D.

Faculty

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026