Riociguat in patients with respiratory disease and hypoxia – a proof-of-concept study

ewcastle Hospitals Foundation NHS Trust0 个研究点目标入组 10 人开始时间: 2015年3月11日最近更新: 2021年5月17日

适应症

试验速览

2017 conference abstract in https://erj.ersjournals.com/content/48/suppl_60/pa2436.abstract (added 07/05/2021) (published 21/05/2017)

•1. Age 40 to 80 years, Male and Female
•2. Primary diagnosis of either chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) with recent stability
•3.Capacity and willingness to provide fully informed consent for participation in the study

•1. On prescribed oxygen therapy, nitrates (tablets or sublingual), dipyridamole, theophylline, warfarin, clopidogrel, rivaroxaban and dabigatran
•2. Other concomitant respiratory diagnoses including asthma, interstitial lung disease (not idiopathic), pulmonary hypertension (of any other aetiology), lung cancer, recent respiratory infection, recent acute pulmonary embolism, recent pneumothora
•3. Unable to give written, informed consent
•Contraindication to spirometry not included elsewhere: recent eye surgery, glaucoma
•4. Uncontrolled arterial hypertension (systolic BP > 180mmHg and/or diastolic BP > 110mmHg
•5. Systolic BP < 95mmHg
•6. Resting awake heart rate < 50 beats per minute or > 105bpm
•7. History of uncontrolled atrial fibrillation within 3 months of screening
•8. Left heart failure with an ejection fraction less than 40%
•9. Hypertrophic Obstructive Cardiomyopathy (HOCM)
•10. Proven or suspected active or recent* coronary artery disease
•11. Other active atherosclerotic disease: active peripheral arterial disease, stroke within 3 months of screening
•12. Significant valvular heart disease
•13. History of active or serious haemoptysis/pulmonary haemorrhage
•14. Hepatic dysfunction
•15. Bilirubin > 2 times ULN at screening and/or
•16. ALT or AST > 3 times ULN at screening and/or
•17. Albumin < 32g/L/hepatic encephalopathy > grade 1 at screening
•18. Renal insufficiency: GFR < 30ml/min
•19. Pregnant or lactating women

发起方

ewcastle Hospitals Foundation NHS Trust