Skip to main content
OpenTrials
Completed

NCT Number: NCT05794932

Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Thrombotic Syndrome Cardiovascular Diseases Claudication, Intermittent Embolism and Thrombosis Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Postthrombotic Syndrome Signs and Symptoms Thrombosis Vascular Diseases Venous Insufficiency Venous Thromboses Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. VO2 max

    Time frame: 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 outcomes

  1. Maximum aerobic power (in Watts)

    Time frame: From baseline and 8 weeks

    Maximum aerobic power is measured in watts before and after venous recanalization

  2. Isowork power

    Time frame: From baseline and 8 weeks

    The isowork power is the power output assessed at the V'O2max before recanalization

  3. Maximal exercise cardiac output (in litres per minute)

    Time frame: 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

  4. Exercise change in Inspiratory capacity (in litres)

    Time frame: 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

  5. Maximal exercise capillary volume (in millilitres)

    Time frame: 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

  6. Maximal exercise O2 arterial pressure (PaO2, in mmHg)

    Time frame: 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

  7. Maximal isometric torque during leg extension (in Newton.meters)

    Time frame: 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

  8. Lower limb extracellular/total water (in %)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ETERecaVSPT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.