EUCTR2021-005032-30-SE进行中（未招募）1 期
An open-label, multicenter study to evaluate the DOSE, efficacy, safety and tolerability of PDNO (Nitrosooxypropanol) infusion in patients with pulmonary hypertension after cardiopulmonary bypass (CPB) surgery for Coronary artery bypass grafting (CABG) or mitral or Aortic valve repair or replacement with or without CABG
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Attgeno AB
- 入组人数
- 40
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
- •1.Ability to understand and willing to sign an ICF after information at the pre-op screening visit.
- •2.Male and female patients, age = 18 years on the date of the informed consent at the time of the pre-op screening visit.*
- •3.Planned to undergo elective cardiopulmonary bypass (CPB) for CABG, AVR or MVR w
- •or w/o CABG. Non-elective (emergency) surgery patients are not eligible. Concomitant
- •CryoMaze procedure and/or surgical left atrial appendix occlusion as a treatment for
- •atrial fibrillation is routinely performed in some of these patients and may be done.
- •4.Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) =40 mmHg, as estimated by doppler defined echocardiography using a modified Bernoulli equation: PASP ˜ 4 (tricuspid regurgitant jet velocity)2 + CVP.
- •*evaluated from medical history
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Patients must not enter the study if any of the following exclusion criteria are fulfilled:
- •1.History of chronic PH (WHO group 1, 3, 4 or 5), not group 2 due to left heart disease, as judged by the Investigator.*
- •2.Patients with contraindications for PAC.
- •3.History of severe chronic obstructive pulmonary disease, as judged by the Investigator.*
- •4.Left heart failure with ejection fraction (EF) <35%.
- •5.Non-ST elevation myocardial infarction [non-STEMI] or ST elevation myocardial infarction [STEMI] within 1 months prior to informed consent.*
- •6.Stroke (CVL), transient ischemic attack (TIA), AV block III within 3 months prior to informed consent or QTcF >450ms at the time of screening.*
- •7.High inotropic requirement (No more than one inotrope treatment and the vasopressor norepinephrine at time of screening/postoperative evaluation).
- •8.(Increased) mediastinal bleeding >100 mL/hour in mediastinal drainage at postoperative evaluation.
- •9.Mechanical circulatory assistance (IABP or R/L VAD).
- •10.Echocardiographic evidence of significant tricuspid insufficiency as judged by the Investigator at screening.*
- •11.Body Mass Index (BMI) >40 kg/m2.*
- •12.Estimated glomerular filtration rate (eGFR) < 30 mL/min preoperative value.
- •13.Methemoglobin >3%.
- •14.Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) (preoperative value).
- •15.Preoperative haemoglobin <10 g/dL, postoperative: Hb < 9 g/dL.
- •16.Thrombocytopenia (platelet count <100,000/mm3), preoperative value.
- •17.Prothrombin time International ratio (INR) > 1.3, preoperative value.
- •18.Pregnant or lactating women, or with a positive pregnancy test at screening (for fertile women only).
- •19. Ongoing daily treatment the last 3 days with non-steroidal anti-inflammatory drugs (NSAIDs, excluding low dose, i.e. 75 mg, acetylsalicylic acid), new oral anticoagulants (NOACs), warfarin, heparin, clopidogrel (last 5 days). Low molecular weight heparin (LMWH) is not an exclusion criterion. Any use of PDE5 inhibitors (sildenafil, tadalafil, vardenafil and avanafil) within 48 hours prior to the administration of PDNO.
- •20.Known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated.*
- •21.History of allergy/hypersensitivity to PD or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to PDNO.*
- •22.History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the ability to participate in the study.*
- •23.Participation in any interventional clinical study or has been treated with any investigational research products within 30 days or 5 half-lives, whichever is longer, prior to the initiation of screening.*
- •*evaluated from medical history
研究者
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