Recovery of Hibernating Myocardium in End Stage Heart Failure (RHIMES-HF)

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.

Study Overview

• Status: Terminated
• Conditions: Ischemic Cardiomyopathy; Myocardial Function After LVAD Implant

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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84143
      • Intermountain Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Proportion of Viable, Hibernating Myocardium and Scar after LVAD Implant	Change in the proportion of viable, hibernating myocardium and scar after LVAD implant, measured using Th-201 Rest-Redistribution Viability Study.	2 weeks prior to LVAD implant and 2 months post LVAD implant

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Intermountain Research and Medical Foundation

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): April 9, 2019

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: Pending (Pending)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO