Recovery of Hibernating Myocardium in End Stage Heart Failure

NCT02573207 | Terminated

• 1 other identifier: Pending
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Function After LVAD Implant; Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Recovery of Myocardial Function

  Recovery of myocardial function assessed continuously, using echocardiographic variables (LVEF, circumferential strain and strain rate, segmental strain and strain rate).

  2 weeks prior to LVAD implant and 1, 2, 3, 4, 6, 9 and 12 months post LVAD implant

Secondary Outcomes (1)

• Change in the Proportion of Viable, Hibernating Myocardium and Scar after LVAD Implant

  2 weeks prior to LVAD implant and 2 months post LVAD implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Intermountain Research and Medical Foundation: collaborator

Study Sites (1)

Intermountain Heart Institute

Murray, Utah, 84143, United States

Location

Study Officials

• Abdallah G Kfoury, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 9, 2015
• Study Start: March 1, 2016
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)