NCT04600115 New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)
| NCT ID | NCT04600115 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Utah |
| Condition | MRI Scans |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-03-03 |
| Primary Completion | 2027-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2017-03-03 with a primary completion date of 2027-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Edward DiBella, Ph.D.
PRINCIPAL INVESTIGATOR
Faculty
Frequently Asked Questions
Who can join the NCT04600115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MRI Scans. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04600115 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04600115 currently recruiting?
Yes, NCT04600115 is actively recruiting participants. Contact the research team at u0447662@umail.utah.edu for enrollment information.
Where is the NCT04600115 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT04600115 clinical trial?
NCT04600115 is sponsored by University of Utah. The principal investigator is Edward DiBella, Ph.D. at Faculty. The trial plans to enroll 100 participants.