NCT04600115

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• MRI Scans

Interventions

Type	Name	Description
DRUG	Adenosine	Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
DRUG	Regadenoson	0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
DRUG	O-15 labeled radioactive water	O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
DEVICE	MRI	Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
DEVICE	PET Imaging	Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day

Timeline

• Start date: 2017-03-03
• Primary completion: 2022-03-03
• Completion: 2023-03-03
• First posted: 2020-10-23
• Last updated: 2020-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study