Investigating Myocardial Remodelling in the Failing Human Heart

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05303896
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Study Start: 2022-05-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2030-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain	1 years	Measurement of myocardial function by in-vivo methods. In-vivo myocardial function will be obtained by MRI and echocardiography. Measurements include LVEF and GLS.
MRI morphological parameters including LVEDV and LVESV.	1 years	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.
Myocardial stiffness measured by MRI and ex-vivo methods.	1 year	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.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway