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Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome (ETERecaVSPT)

Primary Purpose

Post Thrombotic Syndrome, Venous Thromboses, Claudication, Intermittent

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stress test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Thrombotic Syndrome focused on measuring iliac vein, inferior vena cava, exercice tolerance, cardio-pulmonary exercice testing, muscle physiological testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Arnaud de Villeneuve - CHU de MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stress test

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum aerobic power (in Watts)
Maximum aerobic power is measured in watts before and after venous recanalization
Isowork power
The isowork power is the power output assessed at the V'O2max before recanalization
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
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
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
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
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
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

Full Information

First Posted
March 17, 2023
Last Updated
May 3, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05794932
Brief Title
Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome
Acronym
ETERecaVSPT
Official Title
Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
June 17, 2025 (Anticipated)
Study Completion Date
December 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Thrombotic Syndrome, Venous Thromboses, Claudication, Intermittent
Keywords
iliac vein, inferior vena cava, exercice tolerance, cardio-pulmonary exercice testing, muscle physiological testing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress test
Arm Type
Experimental
Arm Description
All patients will undergo a stress test before and after venous recanalization.
Intervention Type
Diagnostic Test
Intervention Name(s)
Stress test
Intervention Description
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 Outcome Measure Information:
Title
VO2 max
Description
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
Time Frame
From baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Maximum aerobic power (in Watts)
Description
Maximum aerobic power is measured in watts before and after venous recanalization
Time Frame
From baseline and 8 weeks
Title
Isowork power
Description
The isowork power is the power output assessed at the V'O2max before recanalization
Time Frame
From baseline and 8 weeks
Title
Maximal exercise cardiac output (in litres per minute)
Description
Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization
Time Frame
From baseline and 8 weeks
Title
Exercise change in Inspiratory capacity (in litres)
Description
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
Time Frame
From baseline and 8 weeks
Title
Maximal exercise capillary volume (in millilitres)
Description
Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization
Time Frame
From baseline and 8 weeks
Title
Maximal exercise O2 arterial pressure (PaO2, in mmHg)
Description
Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization
Time Frame
From baseline and 8 weeks
Title
Maximal isometric torque during leg extension (in Newton.meters)
Description
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
Time Frame
From baseline and 8 weeks
Title
Lower limb extracellular/total water (in %)
Description
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
Time Frame
From baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie MONNIN-BARES, MD
Phone
+334 67 33 59 91
Email
v-monnin@chu-montpellier.fr
Facility Information:
Facility Name
Hopital Arnaud de Villeneuve - CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie MONNIN-BARES, MD
Email
v-monnin@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Fares GOUZI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

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