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

NCT04600115 | Unknown Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB 94980R01HL135328
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study's main specific aims are;

1. 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. 2.Test the new methods for identifying the clinical task of characterizing HFpEF.

Conditions

MRI Scans

Outcome Measures

Primary Outcomes (1)

• Image quality improvement

  comparison of perfusion, myocardial perfusion reserve (MPR), function possibly including strain, and extracellular volume (ECV, from T1 mapping).

  Time in the scanner to be 60-90 minutes.

Study Arms (1)

MRI vs.PET with/without Cardiac disease

EXPERIMENTAL

Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging

Drug: Adenosine; Drug: Regadenoson; Drug: O-15 labeled radioactive water; Device: MRI; Device: PET Imaging

Interventions

Adenosine DRUG

Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion

Also known as: Adenoscan, Adenocard

MRI vs.PET with/without Cardiac disease

Regadenoson DRUG

0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.

Also known as: Lexiscan

MRI vs.PET with/without Cardiac disease

O-15 labeled radioactive water DRUG

O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging

Also known as: O-15 water

MRI vs.PET with/without Cardiac disease

MRI DEVICE

Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson

MRI vs.PET with/without Cardiac disease

PET Imaging DEVICE

Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day

Also known as: Positron Emission Tomography Imaging

MRI vs.PET with/without Cardiac disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

university of Utah, Radiology Research

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Interventions

Adenosine; regadenoson; Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Edward DiBella, Ph.D.

  Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nousheen Alasti, BS

CONTACT

801-585-6142; Nousheen.alasti@hsc.utah.edu

Collin Arsenault, BS.

CONTACT

801-587-8638; collin.arsenault@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 23, 2020
• Study Start: March 3, 2017
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2023
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

US (1)