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Clinical Trials/NCT05303896
NCT05303896
Recruiting
Not Applicable

Investigating Myocardial Remodelling in the Failing Human Heart

Oslo University Hospital1 site in 1 country200 target enrollmentMay 30, 2022
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Oslo University Hospital
Enrollment
200
Locations
1
Primary Endpoint
MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2022
End Date
July 1, 2030
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ivar Sjaastad

Professor

Oslo University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Study Sites (1)

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