chronic thrombo-embolic pulmonary disease without pulmonary hypertension
Conditions
Interventions
All patients are subjected to balloon pulmonary angioplasty (BPA)
patients who will be first randomized to the BPA arm will undergo BPA sessions the first six months and followed by six to 12 months with no intervention and vice versa: patients who will be randomize
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of CTEPD without or with only mild PH (mPAP < 25mmHg and/or PVR < 3WU), confirmed by a multidisciplinary team of CTEPD/CTEPH experts, based on: -acute PE that was objectively diagnosed at least 3 months prior to inclusion and adequately treated -persistent functional limitations: (New York Heart Association (NYHA) class >=2) -persistent radiological perfusion defects, on any adequate perfusion imaging method: >= 3 segmental perfusion defects -a CPET pattern consistent with CTEPD and no other abnormalities explaining the patient’s symptoms 2. patients completed a pulmonary rehabilitation program of at least 8 weeks before randomization. Depending on the local protocol, sessions could be daily or a few times a week 3. qualifying symptom limited CPET were performed after the pulmonary rehabilitation program 4. age 18-80 years 5. Clinical Frailty Scale (CFS) score < 5 (CFS is a 9-point scale that summarizes the overall level of fitness or frailty of an older adult) 6. prior treatment or restart with a therapeutic dose of anticoagulation treatment before randomization
Exclusion criteria
Exclusion criteria: history of BPA or PEAResidual thrombi that are not eligible for BPA, as concluded by the (intervention) radiologists, Major acute or chronic cardiopulmonary comorbidities with an expected impact on survival, exercise capacity and/or gas exchange, e.g. significant coronary heart disease, diastolic/systolic heart failure, pulmonary hypertension (mPAP > 25 mmHg and PVR > 3 WU), severe chronic obstructive pulmonary disease (COPD) GOLD class =3, interstitial lung disease (ILD), disabling neuromuscular disease, malignancyOther forms of PH target therapyinability to undergo exercise testscontrast allergycreatinine clearance < 30ml/minpregnancy or breastfeedingno written informed consentAny condition that makes participation in this study inappropriate or unlikely to complete the trial period in the investigators opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the effect of BPA on the improvement of disease specific quality of life (PEmb-Qol) between the study groups, 6 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcomes include physical performance and endurance measured by the cardiopulmonary exercise test (CPET) and constant Work Rate cycle Test (CWRT), NYHA class and modified BORG scales before and after cardiopulmonary exercise tests at baseline 6 and 12 months following randomization. Furthermore PROMS for functional status (post VTE functional scale), anxiety and depression (hospital anxiety and depression scale (HADS), work productivity (Work Productivity and Activity Impairment) and generic QoL (EQ-5D-5L), at baseline and after 6,12 and 24 months following randomization. Additionally, incidence of serious advers events will be evaluated. | — |
Countries
Netherlands
Contacts
Public ContactJ Es
Amsterdam UMC
Outcome results
None listed