Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

Not Applicable

Recruiting

• Conditions: Venous Thromboses; Claudication, Intermittent; Post Thrombotic Syndrome
• Interventions: Diagnostic Test: Stress test

• Registration Number: NCT05794932
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-03
• Study Start: 2023-04-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-06-17
• Study Completion: 2025-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress test	Stress test	All patients will undergo a stress test before and after venous recanalization.

Primary Outcome Measures

Name	Time	Method
VO2 max	From baseline and 8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Exercise change in Inspiratory capacity (in litres)	From baseline and 8 weeks	Exercise change in Inspiratory capacity is the change between rest and peak exercise of the inspiratory capacity (the volume between end-expiratory volume and total lung capacity) before and after venous recanalization
Maximal exercise O2 arterial pressure (PaO2, in mmHg)	From baseline and 8 weeks	Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization
Maximum aerobic power (in Watts)	From baseline and 8 weeks	Maximum aerobic power is measured in watts before and after venous recanalization
Maximal exercise cardiac output (in litres per minute)	From baseline and 8 weeks	Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization
Maximal exercise capillary volume (in millilitres)	From baseline and 8 weeks	Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization
Isowork power	From baseline and 8 weeks	The isowork power is the power output assessed at the V'O2max before recanalization
Maximal isometric torque during leg extension (in Newton.meters)	From baseline and 8 weeks	Maximal isometric strength during leg extension is the maximal torque of the leg extension at 90° knee flexion assessed by a torque sensor before and after venous recanalization
Lower limb extracellular/total water (in %)	From baseline and 8 weeks	Lower limb extracellular/total water is the water volume int the body compartments in each lower limb, assessed by a segmental bioelectrical impedancemeter before and after venous recanalization

Trial Locations

Locations (1)

Hopital Arnaud de Villeneuve - CHU de Montpellier; 🇫🇷 Montpellier, France