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

longziekten0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•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
•-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

•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

发起方

longziekten