TCTR20200506006已完成3 期
Improved low-risk criteria scores for combination therapy of sildenafil and generic bosentan in patients with congenital heart disease with severe pulmonary hypertension
Medline CO.LTD0 个研究点目标入组 20 人开始时间: 2020年5月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 Years 至 100 Years（—）
- 性别
- All
入选标准
- •: 1) male or female, older than 12 years-of age; 2) patients diagnosed with PAH-CHD, such as Eisenmenger syndrome, PAH with small defect, or PAH after defect correction (We did not include patients with PAH-CHD who were suitable for corrective repair by the 2015 European Society of Cardiology (ESC)/ European Respiratory Society (ERS) pulmonary hypertension (PH) guidelines (4, 9); 3) patients with WHO functional class (1988 WHO functional classification), level I or II who have had a stable disease for at least three months before participating; 4) patients who have had a 6MWD test equal to or greater than 100 m or less than 450 m; 5) patients have not previously been treated with Silkay 125® or any other endothelin receptor antagonist; 6) female patients who are surgically sterile, postmenopausal, or have documented infertility; 7) female patients of childbearing potential using one of the following methods of contraception: barrier-type device (e.g., condom, diaphragm) used only in combination with a spermicide, a double-barrier method is recommended, intrauterine devices (IUDs), or oral or implanted contraceptives, if used in combination with a barrier method; 8) patients providing written informed consent.
排除标准
- •The exclusion criteria were: 1) pregnant patients, nursing mothers; 2) patients with left ventricular dysfunction (ejection fraction < 40%); 3) patients with systolic blood pressure less than 85 mm Hg; 4) patients with other conditions that may affect the ability to perform a 6-minute walk distance test; 5) patients with AST/ALT equal to or more than 3-times the upper limit normal; 6) patients with concurrent use of cyclosporine or glyburide; 7) patients unable to provide informed consent or comply with the patient protocol; 8) patients with planned surgical intervention during the study period; 9) patients with known hypersensitivity to bosentan or any of the excipients.
研究者
相似试验
招募中
4 期
Performance of low risk criteria in the evaluation of direct oral challenge for children with beta-lactam allergy (multicenter study)the patients with low-risk betalactam allergybetalactam allergyTCTR20210225004Ramathibodi hospital400
进行中（未招募）
1 期
Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II StudyCTIS2024-511886-12-00I.F.O. Istituti Fisioterapici Ospitalieri146
招募中
2 期
Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II Study2024-511886-12-00I.F.O. Istituti Fisioterapici Ospitalieri146
招募中
不适用
The new risk scoring system for predicting epithelial ovarian malignancy: Risk of ovarian cancer score (ROCS)Adnexal massOvarian cancerAdnexal mass, Ovarian cancer, Predictive model, Risk scoringTCTR20231103007Srinakharinwirot University124
招募中
不适用
Prediction of cancer-associated venous thromboembolismCancer-associated venous thromboembolismNL-OMON23071Amsterdam UMC2,000