MRI ScansEarly Phase 1NCT04600115
New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)
A Early Phase 1 study testing Adenosine, Regadenoson and O-15 labeled radioactive water in people with MRI Scans, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MRI Scans
- What is being tested?
- Adenosine, Regadenoson and O-15 labeled radioactive water
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 3 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
university of Utah, Radiology Research
Salt Lake City, Utah, 84108
Olivia Pratt, BS, 801-585-6142, u0447662@umail.utah.edu
Collin Arsenault, BS, 801-587-8638, Collin.arsenault@hsc.utah.edu
About this study
This study's main specific aims are;
- 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.
- 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.
- Conditions
- MRI Scans
- Being tested
- Adenosine, Regadenoson, O-15 labeled radioactive water, MRI, PET Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Also called Adenoscan, Adenocard
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
RegadenosonDrug
Also called Lexiscan
0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
O-15 labeled radioactive waterDrug
Also called O-15 water
O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
MRIDevice
Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
PET ImagingDevice
Also called Positron Emission Tomography Imaging
Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day
| Study group | Role | What they receive |
|---|---|---|
| MRI vs.PET with/without Cardiac disease | Experimental | Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging Receives: Drug: Adenosine; Drug: Regadenoson; Drug: O-15 labeled radioactive water; Device: MRI; Device: PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion measured with MRI
Myocardial perfusion measured with Magnetic Resonance Imaging (MRI) at rest and vasodilation
Measured: 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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start3 Mar 2017
- Primary completion3 Mar 2027 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI ScansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Edward DiBella, University of Utah
- Investigators
- Edward DiBella, Ph.D., Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600115
- Sponsor's protocol ID
- IRB 94980
- Other IDs
- R01HL135328
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT04600115
- Acronym / sponsor ID
- IRB 94980
- Conditions
- MRI Scans
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's main specific aims are;
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI vs.PET with/without Cardiac disease | Experimental | Drug: Adenosine, Drug: Regadenoson, Drug: O-15 labeled radioactive water, Device: MRI, Device: PET ImagingAdenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants will be over the age of 18 and able to provide consent
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenosineAlso: Adenoscan, AdenocardAdenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion | Drug | MRI vs.PET with/without Cardiac disease |
| RegadenosonAlso: Lexiscan0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion. | Drug | MRI vs.PET with/without Cardiac disease |
| O-15 labeled radioactive waterAlso: O-15 waterO-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging | Drug | MRI vs.PET with/without Cardiac disease |
| MRIPass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson | Device | MRI vs.PET with/without Cardiac disease |
| PET ImagingAlso: Positron Emission Tomography ImagingQuantitative PET imaging with O-15 labeled radioactive water will be given at a different day | Device | MRI vs.PET with/without Cardiac disease |
Primary outcome
Myocardial perfusion measured with MRI
Time frame: Time in the scanner to be 60-90 minutes.
Myocardial perfusion measured with Magnetic Resonance Imaging (MRI) at rest and vasodilation
1 secondary outcome
ECV measures
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward DiBella, Ph.D. principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adenosine, Regadenoson and O-15 labeled radioactive water in people with MRI Scans, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Pratt, BS (801-585-6142, u0447662@umail.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion measured with MRI (time frame: Time in the scanner to be 60-90 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.