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

NCT ID: NCT07201649

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2029-11-24

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients eligible for Hepatit Transplantation

Patients eligible for HT are contacted by a clinical research coordinator, and if they agree, an inclusion visit is arranged. HT takes place according to transplant availability. As soon as the patient is able to return home after HT, a visit is organised, defining the T1 period. A visit is carried out 120 days after HT and the end-of-study visit is scheduled to define the T2 period, which is the same length as the T1 period for each patient.

Group Type OTHER

a blood test and urine sample collection.

Intervention Type 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.

Interventions

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a blood test and urine sample collection.

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* MELD score \>25, viral replication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume FAVRE, PhD

Role: PRINCIPAL_INVESTIGATOR

CRC, Néphrologie - CHU de Nice - Hôpital de l'Archet

Locations

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CHU de Nice

Nice, Alpes-maritimes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guillaume FAVRE, PhD

Role: CONTACT

+33492039220

Gullaume Marrane

Role: CONTACT

+33492039220

Facility Contacts

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Guillaume FAVRE, PhD

Role: primary

+33492039220

Other Identifiers

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24-PP-15

Identifier Type: -

Identifier Source: org_study_id

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