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NCT Number: NCT05303896

Investigating Myocardial Remodelling in the Failing Human Heart

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0484, Norway

Location status: Recruiting

Location contact

Ivar Sjaastad, MD, PhD

CONTACT

[email protected]

90792893

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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 contacts

Contact information is provided by the study sponsor or research team.

Henrik Dukefoss, MD

CONTACT

[email protected]

95433188

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: RELAX

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Mar 31, 2022
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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