Recovery of Hibernating Myocardium in End Stage Heart Failure
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/30/2018 |
Start Date: | March 2016 |
End Date: | June 2020 |
Contact: | Abdallah G Kfoury, MD |
Email: | boudi.kfoury@imail.org |
Phone: | 801-507-4701 |
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.
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.
Clinical, echocardiographic and hemodynamic data will be obtained from the patients' medical
records. Assessment of viability will be performed using a Tl-201 Rest-Redistribution
Scintigraphy protocol within 2 weeks before LVAD implantation and 2 months after LVAD
implant. Recovery of myocardial function will be assessed using available 2D transthoracic
echocardiographic images and with the novel imaging modality, Speckle Tracking
Echocardiography (STE), in order to provide a regional quantification of the myocardium, in
the context of TL-201 results. Transthoracic echocardiograms will be performed 2 weeks prior
to the LVAD implant and 1, 2, 3, 4, 6, 9, and 12 months after implantation.
records. Assessment of viability will be performed using a Tl-201 Rest-Redistribution
Scintigraphy protocol within 2 weeks before LVAD implantation and 2 months after LVAD
implant. Recovery of myocardial function will be assessed using available 2D transthoracic
echocardiographic images and with the novel imaging modality, Speckle Tracking
Echocardiography (STE), in order to provide a regional quantification of the myocardium, in
the context of TL-201 results. Transthoracic echocardiograms will be performed 2 weeks prior
to the LVAD implant and 1, 2, 3, 4, 6, 9, and 12 months after implantation.
Inclusion Criteria:
1. Male or non-pregnant female >= 18 years of age.
2. End stage chronic and dilated ischemic cardiomyopathy requiring LVAD support.
3. 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.
Exclusion Criteria:
- 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.
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