Clinical trial NCT05794932: Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome
Official title: Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Thrombotic Syndrome
Venous Thromboses
Claudication, Intermittent
Keywords: iliac vein
inferior vena cava
exercice tolerance
cardio-pulmonary exercice testing
muscle physiological testing
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: VO2 max
timeFrame: From baseline and 8 weeks
Secondary outcomes:
measure: Maximum aerobic power (in Watts)
timeFrame: From baseline and 8 weeks
measure: Isowork power
timeFrame: From baseline and 8 weeks
measure: Maximal exercise cardiac output (in litres per minute)
timeFrame: From baseline and 8 weeks
measure: Exercise change in Inspiratory capacity (in litres)
timeFrame: From baseline and 8 weeks
measure: Maximal exercise capillary volume (in millilitres)
timeFrame: From baseline and 8 weeks
measure: Maximal exercise O2 arterial pressure (PaO2, in mmHg)
timeFrame: From baseline and 8 weeks
measure: Maximal isometric torque during leg extension (in Newton.meters)
timeFrame: From baseline and 8 weeks
measure: Lower limb extracellular/total water (in %)
timeFrame: From baseline and 8 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve - CHU de Montpellier
Study officials:
References: