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

NCT07201649 | Recruiting

• 1 other identifier: 24-PP-15
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• hepatic transplantation reduces arterial calcification

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

  On the 7th day after surgery

Secondary Outcomes (2)

• identify arterial calcification related factors

  On the 7th day after surgery

• increase of PPi plasma level after liver transplantation

  at inclusion and at 3 months

Study Arms (1)

Patients eligible for Hepatit Transplantation

OTHER

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.

Other: a blood test and urine sample collection.

Interventions

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.

Patients eligible for Hepatit Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• MELD score \>25, viral replication

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06200, France

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Guillaume FAVRE, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume FAVRE, PhD

CONTACT

+33492039220; favre.g@chu-nice.fr

Gullaume Marrane

CONTACT

+33492039220; marrane.g@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 1, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 24, 2028
• Study Completion (Estimated): November 24, 2029
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (1)