Recovery of Hibernating Myocardium in End Stage Heart Failure

Ischemic Cardiomyopathy Clinical Trial

— RHIMES-HF  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02573207
• Other study ID #: Pending
• Status: Terminated
• Start date: March 2016
• Est. completion date: April 9, 2019

Study information

• Verified date: April 2021
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy
• Myocardial Function After LVAD Implant

Locations

Country	Name	City	State
United States	Intermountain Heart Institute	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Intermountain Research and Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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