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

Primary Purpose

MRI Scans

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Adenosine

Regadenoson

O-15 labeled radioactive water

MRI

PET Imaging

About this trial

This is an interventional health services research trial for MRI Scans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

university of Utah, Radiology ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI vs.PET with/without Cardiac disease

Arm Description

Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging

Outcomes

Primary Outcome Measures

Image quality improvement

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04600115

First Posted

October 21, 2020

Last Updated

October 21, 2020

Sponsor

University of Utah

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04600115

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 3, 2017 (Actual)

Primary Completion Date

March 3, 2022 (Anticipated)

Study Completion Date

March 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study's main specific aims are; 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. Test the new methods for identifying the clinical task of characterizing HFpEF.

Detailed Description

Heart failure with preserved ejection fraction (HFpEF) is currently being studied intensely as several large trials of drug therapies have failed to benefit patients. Better characterization of these patients is important, and there are open questions regarding microvascular disease and remodeling in the HFpEF population. New MRI methods could be ideal to better characterize and understand HFpEF and its response to treatments. This project seeks to develop, evaluate and apply new MRI methods for high-end perfusion imaging. These methods will estimate endo/epi ratios across the cardiac cycle in free-breathing studies, which will provide new information about microvascular disease. This is of particular value for assessing HFpEF. 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. The methods could potentially also predict patients who might respond to particular drug therapies. The new techniques include "simultaneous multi-slice" imaging which has not been used this way for myocardial perfusion imaging. In particular, we are developing an innovative hybrid of the standard saturation pulse and steady state spoiled gradient echo acquisitions. We also are developing a new method for using 3D "stack of stars" + 2D slice in the same scan for arterial input function assessment to quantify perfusion, and new methods for measuring T1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MRI Scans

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI vs.PET with/without Cardiac disease

Arm Type

Experimental

Arm Description

Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging

Intervention Type

Drug

Intervention Name(s)

Adenosine

Other Intervention Name(s)

Adenoscan, Adenocard

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Regadenoson

Other Intervention Name(s)

Lexiscan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

O-15 labeled radioactive water

Other Intervention Name(s)

O-15 water

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PET Imaging

Other Intervention Name(s)

Positron Emission Tomography Imaging

Intervention Description

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

Primary Outcome Measure Information:

Title

Image quality improvement

Description

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

Time Frame

Time in the scanner to be 60-90 minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nousheen Alasti, BS

Phone

801-585-6142

Nousheen.alasti@hsc.utah.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Collin Arsenault, BS.

Phone

801-587-8638

collin.arsenault@hsc.utah.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward DiBella, Ph.D.

Organizational Affiliation

Faculty

Official's Role

Principal Investigator

Facility Information:

Facility Name

university of Utah, Radiology Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nousheen Alasrti, BS

Phone

801-585-6142

Nousheen.Alasti@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Collin Arsenault, BS

Phone

801-587-8638

Collin.arsenault@hsc.utah.edu

12. IPD Sharing Statement

Learn more about this trial

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

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