Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

NCT ID: NCT05794932

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2025-05-15

Brief Summary

Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.

Conditions

Post Thrombotic Syndrome; Venous Thromboses; Claudication, Intermittent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Stress test

All patients will undergo a stress test before and after venous recanalization.

Group Type: EXPERIMENTAL

Stress test

Intervention Type: DIAGNOSTIC_TEST

Diagnostic Test:

• Maximum effort test (CPET) on a cycloergometer
• Leg muscle strength assessment
• Leg muscle mass, composition and water compartments (segmental bioelectrical impedance)
• Spirometry, arterial blood gaz, NO/CO transfer

Interventions

Stress test

Diagnostic Test:

• Maximum effort test (CPET) on a cycloergometer
• Leg muscle strength assessment
• Leg muscle mass, composition and water compartments (segmental bioelectrical impedance)
• Spirometry, arterial blood gaz, NO/CO transfer

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
• Age >= 18 years

Exclusion Criteria

• Contraindication to the performance of a maximal effort test on a cyclo-ergometer
• Refusal of consent after information
• Adult protected by law (guardianship, curatorship)
• Pregnant or breastfeeding woman
• Patient not affiliated to a social security system or not benefiting from such a system

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL22_0560

Identifier Type: -

Identifier Source: org_study_id