Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

Venous Thromboses Clinical Trial

— ETERecaVSPT  

Official title:

Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794932
• Other study ID #: RECHMPL22_0560
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: December 17, 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Montpellier
• Contact: Valérie MONNIN-BARES, MD
• Phone: +334 67 33 59 91
• Email: v-monnin[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 17, 2025
• Est. primary completion date: June 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thromboses
• Venous Thrombosis

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	Hopital Arnaud de Villeneuve - CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum aerobic power (in Watts)	Maximum aerobic power is measured in watts before and after venous recanalization	From baseline and 8 weeks
Secondary	Isowork power	The isowork power is the power output assessed at the V'O2max before recanalization	From baseline and 8 weeks
Secondary	Maximal exercise cardiac output (in litres per minute)	Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization	From baseline and 8 weeks
Secondary	Exercise change in Inspiratory capacity (in litres)	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	From baseline and 8 weeks
Secondary	Maximal exercise capillary volume (in millilitres)	Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization	From baseline and 8 weeks
Secondary	Maximal exercise O2 arterial pressure (PaO2, in mmHg)	Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization	From baseline and 8 weeks
Secondary	Maximal isometric torque during leg extension (in Newton.meters)	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	From baseline and 8 weeks
Secondary	Lower limb extracellular/total water (in %)	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	From baseline and 8 weeks