Balloon pulmonary angioplasty in chronic thromboembolic pulmonary disease without or with mild pulmonary hypertension: BALLOON-TRIA

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of CTEPD without or with only mild PH (mPAP < 25mmHg and 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
-CPET result with:
a) at least 2 of the following criteria:
• peak VO2 < 80%;
• peak O2 pulse < 80% of predicted;
• V*E/V*CO2 @ nadir > 34;
• Vd/Vt increasing until peak exercise or peak Vd/Vt > 0;4;
• gradual drop of SpO2 of >= 3%;
b) these exercise findings cannot be explained otherwise
2. patients completed a pulmonary rehabilitation program of at least 8 weeks no
longer than 2 months before randomization. Depending on the local protocol,
sessions could be daily or a few times a week
3. qualifying symptom limited CPET and CWRT 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. written informed consent
7. prior treatment or restart with a therapeutic dose of anticoagulation
treatment before randomization

Exclusion Criteria

1. history of BPA or PEA
2. residual thrombi that are not eligible for BPA, as concluded by the
(intervention) radiologists,
3. 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), severe chronic obstructive pulmonary disease (COPD) GOLD class >=3,
interstitial lung disease (ILD), disabling neuromuscular disease, malignancy
4. inability to undergo exercise tests
5. contrast allergy
6. creatinine clearance < 30ml/min
7. pregnancy or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the effect of BPA on the improvement of disease specific<br /><br>quality of life (PEmb-Qol) between the study groups, 6 months after<br /><br>randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>secondary outcomes include physical performance and endurance measured by the<br /><br>cardiopulmonary exercise test (CPET) and constant Work Rate cycle Test (CWRT),<br /><br>NYHA class and modified BORG scales before and after cardiopulmonary exercise<br /><br>tests at baseline 6 and 12 months following randomization.<br /><br>Furthermore PROMS for functional status (post VTE functional scale), anxiety<br /><br>and depression (hospital anxiety and depression scale (HADS), work productivity<br /><br>(Work Productivity and Activity Impairment) and generic QoL (EQ-5D-5L), at<br /><br>baseline and after 6,12 and 24 months following randomization. Additionally,<br /><br>incidence of serious advers events will be evaluated. </p><br>