Proactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment. - MIND THE GAP

niversitair Medisch Centrum Groningen0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•1. Diagnosis of upper or lower lobe heterogeneous emphysema with a difference in heterogeneity of >= 25% in destruction at -950HU between ipsilateral lobes.
•2. Subjects of both genders of at least 35 years of age at the time of the baseline visit.
•3. Understand and voluntarily sign a patient informed consent form.
•4. 15 % predicted <= FEV1<= 45% predicted.
•5. RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
•6. 6MWT >= 140 meters.
•7. Dyspnea score of >=2 on the mMRC scale of 0-4.
•8. Non-smoker > 8 weeks prior to signing the informed consent.

•1. Evidence of active pulmonary infection.
•2. Evidence of clinically significant bronchiectasis.
•3. History of more than 3 exacerbations with hospitalizations over the past 12 months.
•4. Evidence of pulmonary hypertension (sPAP > 45mmHg).
•5. Subject has DLCO <20% of predicted.
•6. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
•7. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
•8. Prior endoscopic lung volume reduction.
•9. Unstable pulmonary nodule requiring follow-up.
•10. Pregnant or nursing women.
•11. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
•12. >20mg prednisolon (or equivalent) use/days.
•13. Any disease with high probability of mortality within 24 months.
•14. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins).
•15. Patient was involved in other pulmonary drug studies within 30 days prior to this study.

发起方