NCT05296499

EXERT: Exercise Physiology After Thrombosis

Exercise Physiology After Thrombosis (EXERT): a Prospective Single Centre Cohort Study of Cardiovascular and Exercise Physiology in Patients With Previous Venous Thrombosis in the Inferior Vena Cava and Iliofemoral Veins.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 56 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Deep vein thrombosis (DVT) can cause long-term scarring and narrowing of veins. When there is extensive damage to the veins in the legs, groin or abdomen it can affect the way that blood is able to flow back up to the heart. Some patients are left with severe symptoms such as pain, leg swelling and ulcers, and have surgical treatment with nitinol stents to re-open the veins and relieve symptoms. The primary aim of this study is to investigate venous blood flow to the heart during exercise in patients with extensive damage to the veins in the groin and abdomen after DVT, and changes that happen after stenting.

Detailed description

Participants will have cardiopulmonary exercise testing, 6 minute walk test and basic blood tests to establish exercise tolerance and rule out other heart and lung conditions. Exercise cardiac MRI will be used to evaluate cardiac function during exercise. All participants will complete generic and disease specific quality of life questionnaires. Participants who are having a stenting procedure will repeat assessments 6-8 weeks after surgery.

Conditions

• Venous Thrombosis Deep (Limbs)
• Post Thrombotic Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiopulmonary exercise test (CPET)	Cardiopulmonary exercise testing using cycle ergonomenter
DIAGNOSTIC_TEST	Exercise cardiac MRI	Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET
OTHER	6 minute walk test	6MWT
DIAGNOSTIC_TEST	Blood tests	FBC, U\&E, LFTS
OTHER	Quality of life questionnaires	SF36, EQ5D, VEINES-QoL/Sym
OTHER	Repeat baseline assessments	repeat baseline
DIAGNOSTIC_TEST	MR venogram	MRI scan of venous system

Timeline

• Start date: 2019-09-20
• Primary completion: 2022-10-20
• Completion: 2023-04-20
• First posted: 2022-03-25
• Last updated: 2022-03-25

Locations

1 site across 1 country: United Kingdom