Investigating Myocardial Remodelling in the Failing Human Heart

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05303896

Acronym

RELAX

Enrollment

200

Registered

2022-03-31

Start date

2022-05-30

Completion date

2030-07-31

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

MRI, Heart transplantation, Heart failure, PET

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Norway

Contacts

Primary ContactHenrik Dukefoss, MD

h.b.dukefoss@studmed.uio.no95433188

Outcome results