Investigating Myocardial Remodelling in the Failing Human Heart
RELAX
1 other identifier
observational
200
1 country
1
Brief Summary
Despite improvements in therapy, heart failure is a disease with high mortality and accelerating prevalence. To improve patient care, it is necessary to better understand the features and underlying mechanisms of myocardial remodeling; how it manifests in vivo and its underlying cellular and extracellular changes. The RELAX study will offer insight into myocardial remodeling, by comprehensively assessing function and structure of failing human hearts, and investigate its underlying cellular and extracellular changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
May 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
July 31, 2025
March 1, 2025
8.1 years
March 7, 2022
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain
Measurement of myocardial function by in-vivo methods. In-vivo myocardial function will be obtained by MRI and echocardiography. Measurements include LVEF and GLS.
1 years
MRI morphological parameters including LVEDV and LVESV.
Measurement of myocardial morphology by in-vivo methods including MRI and ultrasound. The expected outcome in regards to morphology is varying degrees of geometrical abnormalities.
1 years
Myocardial stiffness measured by MRI and ex-vivo methods.
Measurement of myocardial stiffness by in-vivo and ex-vivo methods. In-vivo myocardial stiffness will be measured by MRI. The expected outcome is varying degrees of stiffness in accordance with the underlying pathology as well as regionally in the heart. Ex-vivo methods include stiffness measurements by histology and protein analysis.
1 year
Eligibility Criteria
Patients eligible for heart transplantation.
You may qualify if:
- Eligible for heart transplantation
- Willingness to participate in the present study and ability to understand and sign the written informed consent
You may not qualify if:
- Patients under the age of 18.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Oslo County, 0484, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivar Sjaastad, MD, PhD
University of Oslo, Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 7, 2022
First Posted
March 31, 2022
Study Start
May 30, 2022
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2030
Last Updated
July 31, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share