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NCT Number: NCT07201649

Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcifications

Individuals with metabolic syndrome (MetS), particularly those with type 2 diabetes (T2D), and/or metabolic dysfunction-associated steatohepatitis or MASH face an elevated risk of major cardiovascular events (MACE). We showed decrease plams level of PPi in patients with liver cirrhosis. We hypothezised that liver transplant should block AC and restore PPi plasma level.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes-maritimes, 06200, France

Location status: Recruiting

Location contact

Guillaume FAVRE, PhD

CONTACT

[email protected]

+33492039220

Guillaume FAVRE, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • everyone requiring liver transplantation for the treatment of a chronic liver disease

Exclusion criteria

  • MELD score >25, viral replication

Treatment and study plan

a blood test and urine sample collection.

Other

The study is offered to all patients who meet the inclusion criteria during their pre-transplant assessment by the principal investigator (during an existing visit). Patients eligible for HT are contacted by a clinical research coordinator, and if they agree, an inclusion visit is arranged.

Primary outcomes

  1. hepatic transplantation reduces arterial calcification

    Time frame: On the 7th day after surgery

    compare the percent of patients with AC progression before and after liver tranplantation

Secondary outcomes

  1. identify arterial calcification related factors

    Time frame: On the 7th day after surgery

    separation of patients according to AC progression (yes or no) and machine learning analysis with all relevant factors

  2. increase of PPi plasma level after liver transplantation

    Time frame: at inclusion and at 3 months

    comparison of mean plasma levels before and after

Study contacts

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

Guillaume FAVRE, PhD

CONTACT

[email protected]

+33492039220

Gullaume Marrane

CONTACT

[email protected]

+33492039220

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PYROCALM

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 1, 2025
Registry last updated
Dec 1, 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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