Recovery of Hibernating Myocardium in End Stage Heart Failure

Stopped early

Conditions studied: Myocardial Function After LVAD Implant, Ischemic Cardiomyopathy

In brief

This study will collect clinical, echocardiographic, nuclear imaging and hemodynamic data in a group of patients with end stage ischemic cardiomyopathy undergoing left ventricular assist device (LVAD) implantation to investigate the incidence of recovery of myocardial function when supported with LVADs, and to study the association between hibernating myocardium and myocardial recovery in this population.

Key facts

Study ID

NCT02573207

Run by

Intermountain Health Care, Inc.

People needed

2

Starts

2016-03-01

Expected to finish

2019-04-09

Last updated by the study team

2021-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant female >= 18 years of age.
• End stage chronic and dilated ischemic cardiomyopathy requiring LVAD support.
• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
• Ischemic cardiomyopathy is defined by a LVEF < 40% and any of the following:
• History of myocardial infarction or revascularization.
• History of angina or chest pain and evidence of scarring in non-invasive imaging studies corresponding to previous myocardial infarction.
• Presence of ≥ 75% stenosis of the left main or proximal left anterior descending artery, or ≥ 75% stenosis of 2 or more epicardial vessels in a patient with unexplained cardiomyopathy.

You may not qualify if…

• Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
• Patients with acute forms of HF: acute onset of symptoms < 3 months, no left and right ventricular dilation.
• Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Where it is running

• Intermountain Heart Institute — Murray, Utah, United States

Full record on ClinicalTrials.gov

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