RightFit
RecruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This project seeks to develop, evaluate and apply new MRI methods for high-end perfusion imaging."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests new MRI methods to measure blood flow, scarring, and movement in the heart. It aims to better understand heart failure with preserved ejection fraction (HFpEF), where the heart still pumps out a normal share of blood. Adults with or without heart disease may join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be older than 18 and able to agree to take part.
  • Group A: Volunteers with or without heart disease must be available for at least one study visit.
  • Group B: Volunteers must have HFpEF and be able to safely have an MRI.
  • If you receive medicine to stress the heart during MRI, you must avoid caffeine for at least 12 hours before each scan.

Who can't join

  • Children cannot join.
  • You cannot join if you are critically ill, use a breathing machine, have unstable chest pain, have low blood pressure, or have asthma.
  • You cannot join if MRI could put your care or safety at risk, including from metal implants or certain heart valves.
  • You cannot join if fear of tight spaces cannot be controlled with standard medicines.
  • People who are pregnant, have a mental disability, or are prisoners cannot join.
  • You cannot join if your kidney filtering rate (GFR) is below 30 because of risks from gadolinium, an MRI contrast dye. This cutoff may change under radiology and study review board rules.
  • If you have an allergy or another reason you cannot safely receive adenosine or regadenoson, medicines used to stress the heart, you can only join scans that do not use stress medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

UT