100 Participants NeededMy employer runs this trial

New MRI Methods for Heart Failure

CA
NA
OP
Overseen ByOlivia Pratt, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new MRI methods to better understand and diagnose heart failure with preserved ejection fraction (HFpEF), where the heart muscle contracts normally but struggles to relax. Researchers compare MRI to other imaging techniques to evaluate their effectiveness in detecting changes in the heart's small blood vessels and tissue. Participants may receive medications like Adenosine and Regadenoson to enhance blood flow visibility during imaging. Ideal participants include those with a confirmed HFpEF diagnosis who are comfortable undergoing MRI scans. As an Early Phase 1 trial, this research aims to understand how these new MRI methods work in people, offering participants the chance to contribute to groundbreaking advancements in heart failure diagnosis.

What prior data suggests that these methods for studying microvascular cardiac remodeling with MRI are safe?

Previous studies have shown that both adenosine and regadenoson are safe for use in heart imaging. Adenosine is generally well-tolerated, with serious side effects occurring in less than 1% of patients. Doctors use it in stress tests to assess heart function, and most people, even those with severe heart conditions, handle it well.

Regadenoson, another drug for heart imaging, is also considered safe and well-tolerated. Side effects are usually mild and resolve on their own. Common ones include nausea, shortness of breath, and headaches, though these are infrequent.

Overall, both treatments have demonstrated strong safety records in studies, making them reliable options for stress tests and heart imaging.12345

Why are researchers excited about this trial?

Researchers are excited about these new imaging methods because they offer a fresh way to understand heart failure with preserved ejection fraction (HFpEF), a complex condition with limited treatment options. Unlike traditional imaging methods, which often rely on standard MRI or CT scans, this approach uses adenosine and regadenoson alongside O-15 labeled radioactive water for enhanced MRI and PET imaging. This could lead to more precise diagnosis and monitoring by highlighting the heart's blood flow and function in ways that current techniques can't, potentially paving the way for better-targeted therapies in the future.

What evidence suggests that this trial's treatments could be effective for characterizing HFpEF?

This trial will compare the effects of adenosine and regadenoson in cardiac imaging. Research has shown that both adenosine and regadenoson improve blood flow to the heart. Adenosine widens the heart's arteries, boosting blood flow and enhancing heart function. It also manages irregular heartbeats. Regadenoson, a potent stress agent, expands the heart's blood vessels to assess blood flow, aiding in the detection of coronary artery disease. This can provide insights into heart issues such as heart failure. Both treatments help doctors evaluate heart function and better understand heart conditions.678910

Who Is on the Research Team?

ED

Edward DiBella, Ph.D.

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can give consent. It includes healthy volunteers and people diagnosed with heart failure with preserved ejection fraction (HFpEF) who are safe to have an MRI. People with kidney problems, metal implants, certain allergies, claustrophobia, pregnancy, or severe illness cannot join.

Inclusion Criteria

I am over 18 years old and can give my consent.
Group A (volunteers, with or without cardiac disease): Volunteers will be available for at least one study visit
I have HFpEF and can safely have an MRI scan.

Exclusion Criteria

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
Patients with contraindication to MRI (metal implants, or certain types of heart valves)
I cannot safely receive Adenosine or Regadenoson for my scan.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Evaluation

Participants undergo MRI and PET imaging to measure myocardial perfusion and assess cardiac function

60-90 minutes per session
1 visit (in-person)

Follow-up

Participants are monitored for changes in myocardial perfusion and extracellular volume over time

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Adenosine
  • Regadenoson

Trial Overview

The study is testing new MRI methods—sometimes using adenosine or regadenoson stress agents and PET imaging—to better detect changes in the heart's small blood vessels and tissue in HFpEF patients compared to healthy volunteers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MRI vs.PET with/without Cardiac diseaseExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Adenosine as an Adjunctive Therapy for Acute Myocardial ...

This study revealed that adenosine use was associated with an increased incidence of ST resolution, and reduced risk of MACEs.

Adenosine as Adjunctive Therapy and Clinical Outcomes ...

Adenosine was associated with an increased rate of advanced atrioventricular block (RR, 2.72; 95% CI, 1.56-4.74; P <.01) vs placebo, and a ...

Adenosine: Physiology, Pharmacology, and Clinical ...

Chest pain and dyspnea were reported in only 14% of the patient group, with nausea and vomiting in 5% (75). Adenosine was infused for only 3 min at 140 μg/kg/ ...

A meta-analysis utilizing BioMedGPT-LM-7B - Springer Nature

Our data demonstrated that both adenosine/ATP and CCBs exhibit remarkable efficacy in treating SVT, with no notable difference in effectiveness ...

Adenosine - StatPearls - NCBI Bookshelf - NIH

Adenosine is used for its antiarrhythmic properties in supraventricular tachycardia (SVT) and can function as a diagnostic tool, depending on the type of SVT.

Safety profile of adenosine stress cardiac MRI in a tertiary ...

Stress CMR using adenosine in appropriately selected patients is a highly safe procedure with significant side effects seen in less than 1% of patients.

1007 Tolerance and safety of adenosine stress perfusion ...

In a large series, the use of intravenous adenosine in CMR perfusion imaging is safe and well tolerated in patients with even severe CAD. If a careful screening ...

Feasibility and safety of high-dose adenosine perfusion ...

A high-dose adenosine protocol (up to 210 mcg/kg/min) is well tolerated and results in adequate haemodynamic response in nearly all patients.

Lexiscan, Adenoscan May Put Patients at Risk for Heart Attack ...

Lexiscan, Adenoscan May Put Patients at Risk for Heart Attack, Death. radiopharmaceuticals and tracers nuclear molecular imaging FDA lexiscan.

Adenosine Stress Test

Researchers proved the safety of adenosine for a stress test by evaluating 15,000 people who received it. What does adenosine do to your heart ...