Assessing the Effects of Mechanical Unloading on Repair Version-1

NCT06026215 | Completed

• 2 other identifiers: 2015CD001139009
• Study Type: observational
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The mechanism by which heart failure initiates and progresses and the mechanisms of heart repair remain unclear. The left ventricular assist device (LVAD) is a therapy to stabilise patients while they await their transplant. The LVAD helps pump blood around the body, giving the heart an opportunity to recover. During surgery, the apical core tissue is routinely removed to allow the implantation of the device (this tissue is normally discarded). Some patients demonstrate cardiac recovery, allowing the device to be removed without later needing a transplant. As part of the LVAD removal procedure, the section around the device might need to be removed (this tissue is normally discarded). To further understand the cellular and molecular mechanisms by which the heart is repaired, the investigators wish to utilise this surplus tissue for research purposes. The collection of this tissue is part of routine treatment and does not represent additional risk for the patient for research purposes. Some patients might still require a transplant following VAD treatment. The native heart is removed from these patients (routinely discarded) and replaced by a donor heart. The investigators wish to utilise this discarded tissue for research purposes, so that the investigators can identify the cellular and molecular factors involved in cardiac repair and which distinguish responsive and non-responsive patients. Heart transplant recipients who require extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for research purposes when performed as part of routine clinical practice. There is no additional risk to the patient for research purposes. Heart failure patients scheduled for transplantation (who have not received a VAD) will be recruited prior to transplantation and their native heart retained for research purposes. An additional peripheral blood sample will be collected from all patients for research purposes when performed for routine clinical practice.

Conditions

Heart Failure; Transplant; Failure, Heart

Outcome Measures

Primary Outcomes (1)

• Changes in protein expression within the tissue during clinical repair.

  Relate small changes in protein expression within the heart tissue to clinical parameters indicative of function. Additionally, the investigators aim to extend our understanding of the mechanisms underpinning heart failure by identifying the factors responsible for either preventing repair or promoting expedited disease progression.

  through study completion - 4 years

Study Arms (3)

Group 1

Heart failure patients requiring ventricular assist device implantation will be included into group 1.

Group 2

Heart transplant recipients requiring early extracorporeal membrane oxygenation will be recruited into group 2.

Group 3

Heart transplant recipients who have not previously received a VAD will be recruited into group 3.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic heart failure and require mechanical unloading using a left ventricular assist device.

You may qualify if:

• Patients must be able to provide informed consent; informed consent may be provided retrospectively if this cannot be provided pre-surgery.
• Patients must be aged between 18--70 years of age.
• Patients who have been clinically diagnosed with chronic heart failure and require mechanical unloading using a left ventricular assist device.
• Patients who have received a heart transplant but require extracorporeal membrane oxygenation.

You may not qualify if:

• Patients under 18 or over 70 years of age.
• Patients unable to provide informed consent.
• Patients who are prisoners.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 7, 2023
• Study Start: January 15, 2015
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 7, 2023

Record last verified: 2023-09