Investigating Myocardial Remodelling in the Failing Human Heart

Heart Failure Clinical Trial

— RELAX  

Official title:

Investigating Myocardial Remodelling in the Failing Human Heart

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303896
• Other study ID #: 230524
• Status: Recruiting
• Start date: May 30, 2022
• Est. completion date: July 2030

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: Henrik Dukefoss, MD
• Phone: 95433188
• Email: h.b.dukefoss[@]studmed.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2030
• Est. primary completion date: July 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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