Myocardial Fibrosis, Function and Aging (MARVEL)

Myocardial Fibrosis and Changes of Myocardial Function Related to Aging

In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as diastolic function is reported to change according to age. The objective is to explore the relationship between myocardial function changes, with local (T1 and diffusion) fibrosis measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin auto-fluorescence and collagen blood-biomarkers).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Blood sampling; Device: MRI; Biological: Skin auto-fluorescence

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42270
    • Département de Radiologie, CHU Saint-Etienne - Hôpital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• physical activity ≤ 3 x(30') per week
• no history of smoking, diabetes, myocardial infarction, heart failure, hypertension (<140 or <90 mmHg) and no anti-hypertensive or cardiovascular-related medications
• no familial history of early myocardial ischemia
• body mass index (BMI) <30kg/m2
• normal routine lipid blood analysis
• glycemia <1.26g/l
• normal electrocardiogram (ECG)

Exclusion Criteria:

• arrhythmia
• hepatic insufficiency
• pregnancy
• claustrophobia
• MRI contrast allergy,
• general contraindications to MRI such as pacemaker, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy volunteers; Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed

Biological: Blood sampling; Blood sampling will be performed at inclusion to investigate some biological eligibility criteria, and the day of MRI in order to analyse fibrosis biomarkers and collagen synthesis biomarkers; Device: MRI; MRI will be performed to measure interstitial fibrosis; Biological: Skin auto-fluorescence; Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional myocardial strain	Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)	The day of MRI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI T1 value	This value is an indicator of interstitial fibrosis and extracellular volume	The day of MRI, before gadolinium injection
MRI T1 value	Diminution of this value after gadolinium injection is an indicator of increasing quantity of interstitial fibrosis and extracellular volume	The day of MRI, 15 minutes after gadolinium injection
Apparent Diffusion Coefficient (ADC) with MRI	ADC is measured with diffusion weighted imaging	The day of MRI
Blood carboxy-terminal propeptide of procollagen type I (PICP) rate	Collagen blood biomarker analysis	The day of MRI
Blood amino-terminal propeptide of procollagen type III (PIIINP) rate	Collagen blood biomarker analysis	The day of MRI
Advanced Glycation End-products (AGE) rate	Skin auto-fluorescence AGE measures	The day of MRI

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Pierre CROISILLE, MD, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ageing; cardiac function; myocardial fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 69HCL15_0744

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No