Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

NCT05794932 | Completed

• 1 other identifier: RECHMPL22_0560
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

iliac vein; inferior vena cava; exercice tolerance; cardio-pulmonary exercice testing; muscle physiological testing

Outcome Measures

Primary Outcomes (1)

• VO2 max

  Change in VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise from baseline to 8 weeks. It is measured in liters of O2 per minute

  From baseline and 8 weeks

Secondary Outcomes (8)

• Maximum aerobic power (in Watts)

  From baseline and 8 weeks

• Isowork power

  From baseline and 8 weeks

• Maximal exercise cardiac output (in litres per minute)

  From baseline and 8 weeks

• Exercise change in Inspiratory capacity (in litres)

  From baseline and 8 weeks

• Maximal exercise capillary volume (in millilitres)

  From baseline and 8 weeks

Study Arms (1)

Stress test

EXPERIMENTAL

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

Diagnostic Test: Stress test

Interventions

Stress test 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

Stress test

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hopital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis; Intermittent Claudication

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 3, 2023
• Study Start: April 17, 2023
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)