Status:
RECRUITING
Impact on Quality of Life with Pulmonary RehAbilitation After Pulmonary EMBOlism: RAMBO Study
Lead Sponsor:
University Hospital, Brest
Conditions:
Pulmonary Embolism
Quality of Life and Dyspnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pulmonary Embolism (PE) is a common and serious disease. Indeed, the annual incidence is 1/1000 patients per year and the 3-month mortality is 10%, which is twice that of myocardial infarction. The tr...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patient treated with at least 3 months and up to 8 months of anticoagulation for symptomatic EP diagnosed according the ESC and ACCP guidelines.
- Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q7+8 (dyspnea) and Q4 (impact of daily life) are ≥ 10%.
Exclusion
- Presence of CTEPH according to international guidelines
- Patients treated for acute PE with anticoagulants for more than 8 months
- Active cancer or in remission for less than two years
- Dyspnea post - COVID due to parenchymal injuries
- Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae.
- Physical or psychological inability to undertake PR
- Isolated or more distal segmental PE
- Neuro-muscular disease with PR contraindication.
- Cardiac insufficiency (unstable coronary artery disease)
- Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)
- Chronic dyspnea MMRC ≥ 2 before PE
- Cardiac or respiratory rehabilitation in the previous year
- Indication to urgent PR within 6 months at the time of inclusion
- Life expectancy of less than 12 months
- Inability to give consent
- Patient under guardianship or curatorship
- Patient deprived of liberty by an administrative or judicial decision
- Patient has not social security affiliation or who don't beneficiary of such social security
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05015153
Start Date
May 11 2022
End Date
February 1 2028
Last Update
December 16 2024
Active Locations (9)
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1
CHU Brest
Brest, France, France, 29609
2
CHU Angers
Angers, France, 49100
3
CHU de Grenoble
Grenoble, France, 38048
4
CHBS Lorient
Lorient, France, 56100