Status:
UNKNOWN
EXERT: Exercise Physiology After Thrombosis
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Venous Thrombosis Deep (Limbs)
Post Thrombotic Syndrome
Eligibility:
All Genders
16+ years
Brief 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 fl...
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 wil...
Eligibility Criteria
Inclusion
- All groups:
- \>16 years of age
- \- Consent to participate in the research study and be willing to commit to study requirements, including completion of questionnaires and follow up visits.
- Group 1:
- Venous thrombosis/obstruction involving the inferior vena cava \>12 months ago.
- Symptoms of exertional dyspnoea reported by patient.
- Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
- Agree to adhere to therapeutic anticoagulation after surgical intervention.
- Group 2:
- Venous thrombosis/obstruction involving the inferior vena cava \>12 months ago.
- Under the clinical care of the deep venous service for surveillance of symptoms.
- Group 3:
- Unilateral Iliofemoral venous thrombosis /obstruction \>12 months ago.
- Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
- Agree to adhere to therapeutic anticoagulation after surgical intervention.
Exclusion
- All groups:
- DVT or PE in last 12 months
- Significant or untreated left sided heart disease (eg coronary artery disease, LV dysfunction, valvular abnormalities, congenital heart disease, chronic or paroxysmal arrhythmias)
- Significant or untreated chronic lung disease (eg asthma, COPD, ILD)
- Moderate to severe renal disease
- Moderate to severe liver disease
- Peripheral arterial disease
- Significant neurological or musculoskeletal disease
- Cognitive impairment or learning disabilities
- Pregnant or planning to become pregnant in next 12 months
- Active cancer (primary, metastatic or treated within last 6 months)
- Life expectancy \< 2 years or chronic non-ambulatory status.
- Any other contraindication to exercise.
- Any contraindications to MRI scanning
- Inability to provide informed consent or comply with study assessments (e.g. due to cognitive impairment, physical limitations or geographic distance).
- Group 4:
- All of the above, plus:
- Previous DVT or PE
- Known, or clinical signs of chronic venous disease as judged by the chief investigator e.g. varicose veins, leg ulcers.
Key Trial Info
Start Date :
September 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 20 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05296499
Start Date
September 20 2019
End Date
April 20 2023
Last Update
March 25 2022
Active Locations (1)
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1
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH