Investigating Myocardial Remodelling in the Failing Human Heart (RELAX)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Henrik Dukefoss, MD; Phone Number: 95433188; Email: h.b.dukefoss@studmed.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0484
    • Recruiting
    • Oslo University Hospital
    • Contact: Ivar Sjaastad, MD, PhD; Phone Number: 90792893; Email: ivar.sjaastad@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for heart transplantation.

Description

Inclusion Criteria:

• Eligible for heart transplantation
• Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

• Patients under the age of 18.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Ivar Sjaastad, MD, PhD, University of Oslo, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: MRI; PET; Heart failure; Heart transplantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 230524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No