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

NCT04600115 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-23

No results posted yet for this study

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.

Conditions

  • MRI Scans

Interventions

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Utah

    lead OTHER

Principal Investigators

  • Edward DiBella, Ph.D. · Faculty

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2022-03-03
Completion
2023-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04600115 on ClinicalTrials.gov