COMbination therapy for PulmonAry hypertension using RacEcadotril (COMPARE): a randomised trial

niversity College London (UK)0 个研究点目标入组 21 人开始时间: 2013年6月28日最近更新: 2019年10月7日

试验速览

•1. WHO Group I pulmonary hypertension (i.e. idiopathic, familial or associated with connective tissue diseases
•2. 18-80 years old
•3. Technically satisfactory routine right heart catheterisation (Step 1 only)*
•4. On sildenafil (20-100 mg; t.i.d.)
•5. Six minute walk distance of >150 m
•6. No changes to PH specific therapies for 1 month
•7. Not pregnant (women only). Women of child-bearing potential must have a negative pregnancy test within seven days prior to randomisation they must be willing to use an effective method of contraception (including hormonal or barrier method of birth control) from the time consent is signed until six weeks after treatment discontinuation.
•8. Able to provide consent for the trial
•* Technically satisfactory means that the PI or delegated physician is content that the patient is able to have the catheter in for longer and that the necessary trial information is able to be extracted.
•9. Target Gender: Male & Female

•1. Known sensitivity to racecadotril or its excipients
•2. Clinical diagnosis of liver cirrhosis or ALT/AST >2 X ULN
•3. Kidney disease with an eGFR of <50 ml/min
•4. History of angioedema
•5. Systolic blood pressure <85 mmHg
•6. Known history of drug or alcohol abuse within six months of enrolment
•7. Participation in a clinical study involving another investigational drug
•8. Women who are breastfeeding
•9. Patients taking ACE inhibitors
•10.Any clinical condition for which the investigator would consider the patient unsuitable for the trial

发起方

niversity College London (UK)