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Recruiting NCT05303896

Investigating Myocardial Remodelling in the Failing Human Heart

Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain [Time frame: 1 years]
  • MRI morphological parameters including LVEDV and LVESV. [Time frame: 1 years]
  • Myocardial stiffness measured by MRI and ex-vivo methods. [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT05303896 · 230524

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗