HealthyMARVELNCT03064503
Myocardial Fibrosis, Function and Aging
A study testing Blood sampling, MRI and Skin auto-fluorescence in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood sampling, MRI and Skin auto-fluorescence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2017to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- arrhythmia
- hepatic insufficiency
- pregnancy
- claustrophobia
- MRI contrast allergy,
- general contraindications to MRI such as pacemaker, etc.
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Radiologie, CHU Saint-Etienne - Hôpital Nord
Saint-Etienne, 42270
About this study
Official title: 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).
- Conditions
- Healthy
- Being tested
- Blood sampling, MRI, Skin auto-fluorescence
- Keywords
- myocardial fibrosis, cardiac function, ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
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
MRIDevice
MRI will be performed to measure interstitial fibrosis
Skin auto-fluorescenceBiological
Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed Receives: Biological: Blood sampling; Device: MRI; Biological: Skin auto-fluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional myocardial strain
Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)
Measured: The day of MRI
Secondary outcomes (6)
MRI T1 value
This value is an indicator of interstitial fibrosis and extracellular volume
Measured: 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
Measured: The day of MRI, 15 minutes after gadolinium injection
Apparent Diffusion Coefficient (ADC) with MRI
ADC is measured with diffusion weighted imaging
Measured: The day of MRI
Blood carboxy-terminal propeptide of procollagen type I (PICP) rate
Collagen blood biomarker analysis
Measured: The day of MRI
Blood amino-terminal propeptide of procollagen type III (PIIINP) rate
Collagen blood biomarker analysis
Measured: The day of MRI
Advanced Glycation End-products (AGE) rate
Skin auto-fluorescence AGE measures
Measured: The day of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start20 Feb 2017
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre CROISILLE, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064503
- Sponsor's protocol ID
- 69HCL15_0744
- Acronym
- MARVEL
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2017
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Fibrosis and Changes of Myocardial Function Related to Aging
- ClinicalTrials.gov ID
- NCT03064503
- Acronym / sponsor ID
- MARVEL / 69HCL15_0744
- Conditions
- Healthy
- Keywords
- myocardial fibrosis, cardiac function, ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Biological: Blood sampling, Device: MRI, Biological: Skin auto-fluorescenceSedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- arrhythmia
- hepatic insufficiency
- pregnancy
- claustrophobia
- MRI contrast allergy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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 | Biological | Healthy volunteers |
| MRIMRI will be performed to measure interstitial fibrosis | Device | Healthy volunteers |
| Skin auto-fluorescenceSkin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation | Biological | Healthy volunteers |
Primary outcome
Regional myocardial strain
Time frame: The day of MRI
Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)
6 secondary outcomes
MRI T1 value
Time frame: The day of MRI, before gadolinium injection
MRI T1 value
Time frame: The day of MRI, 15 minutes after gadolinium injection
Apparent Diffusion Coefficient (ADC) with MRI
Time frame: The day of MRI
Blood carboxy-terminal propeptide of procollagen type I (PICP) rate
Time frame: The day of MRI
Blood amino-terminal propeptide of procollagen type III (PIIINP) rate
Time frame: The day of MRI
Advanced Glycation End-products (AGE) rate
Time frame: The day of MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
Related trials for Healthy
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre CROISILLE, MD, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, MRI and Skin auto-fluorescence in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional myocardial strain (time frame: The day of MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.