Clinical trial NCT02573207: Recovery of Hibernating Myocardium in End Stage Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myocardial Function After LVAD Implant
Ischemic Cardiomyopathy
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Intermountain Research and Medical Foundation
First posted: 2015-10-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>= 18 years old) with end stage ischemic cardiomyopathy receiving a LVAD at the U.T.A.H. Cardiac Transplant Program. We will exclude subjects with acute forms of heart failure and patients with left ventricular ejection fraction (LVEF) \< 40% and non-obstructive coronary artery disease.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recovery of Myocardial Function
timeFrame: 2 weeks prior to LVAD implant and 1, 2, 3, 4, 6, 9 and 12 months post LVAD implant
Secondary outcomes:
measure: Change in the Proportion of Viable, Hibernating Myocardium and Scar after LVAD Implant
timeFrame: 2 weeks prior to LVAD implant and 2 months post LVAD implant
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Heart Institute
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: Abdallah G Kfoury, MD
role: PRINCIPAL_INVESTIGATOR
References: