Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06026215
Other study ID # 2015CD001
Secondary ID 139009
Status Completed
Phase
First received
Last updated
Start date January 15, 2015
Est. completion date May 31, 2019

Study information

Verified date September 2023
Source Manchester University NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients under 18 or over 70 years of age. - Patients unable to provide informed consent. - Patients who are prisoners.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Manchester University NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy