Myocardial Function After LVAD ImplantRHIMES-HFNCT02573207
Recovery of Hibernating Myocardium in End Stage Heart Failure
An observational study of Myocardial Function After LVAD Implant and Ischemic Cardiomyopathy, run by Intermountain Health Care, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Function After LVAD Implant, Ischemic Cardiomyopathy
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 9 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Myocardial Function
Recovery of myocardial function assessed continuously, using echocardiographic variables (LVEF, circumferential strain and strain rate, segmental strain and strain rate).
Measured: 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
Change in the proportion of viable, hibernating myocardium and scar after LVAD implant, measured using Th-201 Rest-Redistribution Viability Study.
Measured: 2 weeks prior to LVAD implant and 2 months post LVAD implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startMar 2016
- Primary completion9 Apr 2019
- Study completion9 Apr 2019
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Function After LVAD ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Abdallah G Kfoury, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573207
- Sponsor's protocol ID
- Pending
- Acronym
- RHIMES-HF
- Status last verified
- Apr 2021
- First submitted
- 7 Oct 2015
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Hibernating Myocardium in End Stage Heart Failure
- ClinicalTrials.gov ID
- NCT02573207
- Acronym / sponsor ID
- RHIMES-HF / Pending
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Study start
- Mar 2016
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery of Myocardial Function
Time frame: 2 weeks prior to LVAD implant and 1, 2, 3, 4, 6, 9 and 12 months post LVAD implant
Recovery of myocardial function assessed continuously, using echocardiographic variables (LVEF, circumferential strain and strain rate, segmental strain and strain rate).
1 secondary outcome
Change in the Proportion of Viable, Hibernating Myocardium and Scar after LVAD Implant
Time frame: 2 weeks prior to LVAD implant and 2 months post LVAD implant
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah G Kfoury, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Function After LVAD Implant and Ischemic Cardiomyopathy, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Myocardial Function (time frame: 2 weeks prior to LVAD implant and 1, 2, 3, 4, 6, 9 and 12 months post LVAD implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.