EUCTR2018-002509-78-GB进行中（未招募）1 期
Beta-blockers Or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP Trial). A blinded, UK multi-centre, clinical effectiveness and cost-effectiveness randomised controlled trial. - Beta-blockers or placebo for primary prophylaxis (BOPPP) of oesophageal varices trial.
Kings College Hospital NHS Foundation Trust0 个研究点目标入组 1,200 人开始时间: 2019年1月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •o Age 18 years and over
- •o Cirrhosis and portal hypertension, defined by any 2 of the following:
- •1) Characteristic clinical examination findings; one or more of:
- •Characteristic liver function tests
- •Haematological panel
- •Coagulation profile abnormalities
- •2)Characteristic radiological findings; one or more of
- •Heterogeneous liver with irregular contour
- •splenomegaly
- •recanalized umbilical vein
- •3) FibroScan liver stiffness measurement >15 kPa without other explanation
- •4) Fibrosis score > stage 4 on liver biopsy (presence of a relevant fibrosis score by biopsy does not require additional clinical examination / radiological / FibroScan supporting evidence)
- •oSmall oesophageal varices diagnosed within the last 6 months, defined as =5 mm in diameter or varices which completely disappear on moderate insufflation at gastroscopy.
- •oNot received a beta-blocker in the last week
- •oCapacity to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1200
排除标准
- •o Non-cirrhotic portal hypertension
- •o Medium/large oesophageal varices (current or history [decreasing in size without curative therapy), defined as >5 mm in diameter
- •o Gastric (IGV and GOV2), duodenal, rectal varices with or without evidence of recent bleeding. For gastric varices, this includes:
- •? IGV-1 and IGV-2 (isolated gastric varices)
- •? GOV2 (gastric varices continuing into the cardia)
- •? Note GOV1 (gastric varices continuing into the lesser curve) are not an exclusion if present with small oesophageal varices
- •o Previous variceal haemorrhage
- •o Previous band ligation or glue injection of oesophageal and/or gastric varices
- •o Red signs accompanying varices at endoscopy
- •o Known intolerance to beta blockers
- •o Contraindications to beta blocker use:
- •Heart rate <50 bpm
- •Known 2nd degree or higher heart block
- •Sick sinus syndrome
- •Systolic blood pressure <85 mmHg
- •Chronic airways obstruction (asthma/COPD)
- •Floppy Iris Syndrome
- •CYP2D6 Poor Metaboliser
- •History of cardiogenic shock
- •History of severe hypersensitivity reaction to beta-blockers
- •Untreated phaeochromocytoma
- •Severe peripheral vascular disease
- •Prinzmetal angina
- •NYHA IV heart failure
- •o Unable to provide informed consent
- •o Child Pugh C cirrhosis
- •o Already receiving a beta-blocker for another reason that cannot be discontinued
- •o Graft cirrhosis post liver transplantation
- •o Evidence of active malignancy without curative therapy planned
- •o Pregnant or lactating women
- •o Women of child bearing potential not willing to use adequate contraception during the period of IMP dosing (1 week washout period)
- •o Patients who have been on a CTIMP within the previous 3 months
研究者
相似试验
进行中（未招募）
4 期
Beta-blockers or placebo for primary prophylaxis of oesophageal varices trialParticipants with cirrhosis and small varices without evidence of previous bleedingCirculatory SystemOesophageal varicesISRCTN10324656King’s College Hospital NHS Foundation Trust763
已完成
3 期
Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCIMyocardial infarctionNL-OMON41647Maatschap cardiologie Isala450
进行中（未招募）
不适用
Early Beta blocker Administration before reperfusion in patients with a myocardial infarction who are planned to undergo a percutaneous coronary intervention within 12 hoursPatients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplastyMedDRA version: 16.1Level: LLTClassification code 10066641Term: Acute myocardial infarction, of anterior wallSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10068109Term: Anterolateral myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10000918Term: Acute myocardial infarction, of other specified sites, initial episode of careSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10066673Term: Transmural myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10067273Term: Acute transmural myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 10007541 - Cardiac disordersEUCTR2010-023394-19-ESMaatschap Cardiologie Isala klinieken408
进行中（未招募）
1 期
Early Beta blocker Administration before reperfusion in patients with a myocardial infarction who are planned to undergo a percutaneous coronary intervention within 12 hoursPatients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplastyMedDRA version: 18.0Level: LLTClassification code 10066641Term: Acute myocardial infarction, of anterior wallSystem Organ Class: 100000004849EUCTR2010-023394-19-NLMaatschap Cardiologie Isala601
已完成
不适用
Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)CirrhosisNCT00772057Govind Ballabh Pant Hospital164