New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)
Recruiting · NCT04600115 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Utah
View the official record on ClinicalTrials.gov →Interventions studied
AdenosineMRIO-15 labeled radioactive waterPET ImagingRegadenoson
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- university of Utah, Radiology Research - Salt Lake City, Utah, United States