Understanding the Mechanisms of Diastolic Dysfunction

Withdrawn before enrolling · Not applicable

Conditions studied: Heart Failure With Preserved Ejection Fraction, Healthy

In brief

Heart failure is a clinical syndrome marked by breathlessness, even at low levels of exertion, general fatigue, and fluid retention and is estimated to affect 5.1 million people in the United States. Heart failure with preserved ejection fraction (HFpEF) means that the heart pumps enough blood to the body, but patients still have terrible symptoms. It is estimated to account for about 50% of all heart failure cases. Experts agree that impaired filling of the heart, perhaps due to "stiffness" of the heart muscle itself, critically underlies HFpEF. There is currently no clinical technique for measuring heart muscle (myocardial) stiffness; the very definition of "myocardial stiffness" remains poorly established. Consequently, the ability to study the mechanisms that underlie HFpEF is virtually non-existent, and limited treatment options will persist without significant advances. The objective of this project is to use an Equilibrium-Material-Stability (EMS) framework that couples patient-specific clinical MRI and heart pressure data in a computational model of the heart to diagnose changes in myocardial stiffness. The central hypothesis is that the new EMS framework for understanding the mechanisms of diastolic dysfunction in HFpEF will be more sensitive and outperform currently available approaches.

Key facts

Study ID

NCT03340233

Run by

University of California, Los Angeles

People needed

0

Starts

2018-06-01

Expected to finish

2022-08-01

Last updated by the study team

2019-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers
• Healthy adults
• Patients with Heart Failure with Preserved Ejection Fraction
• Patient scheduled for catheterization at UCLA Medical Center
• Ejection fraction >/= 50%
• Signs and symptoms of heart failure
• Excluded other potential non-cardiac etiologies of heart failure

You may not qualify if…

• Healthy volunteers
• Known medical condition that impacts heart health
• Contraindications to MRI (e.g., pacemaker/ICD, or claustrophobia)
• Patients with Heart Failure with Preserved Ejection Fraction
• Exclusion Criteria:
• Contraindications to MRI (e.g., pacemaker/ICD, or claustrophobia)
• Prior MI or history of PCI/CABG
• Worse than mild valvular disease
• Any indication for ICD implantation
• Contraindication to MRI contrast agents or eGRF <30 ml/min/1.73m2 or MRI exams (e.g., pacemaker/ICD or claustrophobia).
• Atrial fibrillation or unstable cardiac rhythm

Where it is running

• University of California Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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