EUCTR2014-001882-28-DE进行中（未招募）1 期
Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
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.Male or female SSc patients with borderline - PAH and:
- •2.mPAP 21-24 mmHg, transpulmonary gradient >11 mmHg, as defined by the current ESC Guidelines, PAWP <15 mmHg and/or
- •3.Exercise induced elevated mPAP-values >30 mmHg, (PAWP <18 mmHg; TPG =15 mmHg, as defined in Saggar et al. (2012)) without left heart or severe lung disease or systemic arterial hypertension
- •4.Adult patients having completed his/her 18th birthday
- •5.Patients with definite diagnosis of Systemic Sclerosis using the scleroderma criteria of the American Rheumatism Association
- •6.SSc - disease duration >3 years
- •7.Able to understand and willing to sign the Informed Consent Form
- •8.Negative pregnancy test at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1.Any connective tissue diseases (CTD) other than SSc
- •2.Pulmonary hypertension (PH) confirmed by right heart catheter (RHC) before enrolment, i.e. mPAP =25 mmHg at rest
- •3.Patients presenting normal mPAP values, i.e. mPAP<21 mmHg at rest, and mPAP =30 mmHg during exercise, and/or PAWP =15 mmHg at rest or =18 mmHg during exercise
- •4.Ongoing or a history of >2 weeks of continued use of therapies that are considered definitive PH treatment: endothelin receptor antagonists (ERA; e.g. bosentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), and prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost) and soluble guanylate cyclase stimulator (e.g. Riociguat). Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted.
- •5.Except for diuretics and corticosteroids medical treatment should not be expected to change 4 weeks prior inclusion into the study and during the entire 12-week study period.
- •6.Known intolerance to ambrisentan or one of its excipients
- •7.Clinically significant anemia (hemoglobin concentration of less than 75% of the lower limit of normal, LLN)
- •8.Forced vital capacity (FVC) <60%, forced expiratory volume in first second (FEV1) <65%
- •9.Severe interstitial lung disease, idiopathic pulmonary fibrosis
- •10.Renal insufficiency (glomerular filtration rate [GFR] <60 mL/min/1.73m2 at least for the last 3 months before inclusion)
- •11.Baseline values of hepatic aminotransferases (ALT and/or AST) >3 x upper limit of normal (ULN)
- •12.Systolic blood pressure <85 mmHg;
- •13.evidence of inadequately treated blood pressure >160/90 mmHg and/or blood pressure during exercise >220/120 mmHg
- •14.Patients referred with clinically significant overt heart failure
- •15.Clinically significant fluid retention
- •16.Previous evidence or diagnosis of clinically relevant left heart disease, i.e. at least one of the following: Previous echocardiography with estimated left ventricular (LV) ejection fraction <50%, previous history of cardiogenic pulmonary edema, increased size of left atrium (>50 mm)
- •17.Known significant diastolic dysfunction associated with clinical heart failure
- •18.Known coronary disease or significant valvular heart disease
- •19.Known congenital heart defects such as single ventricle, transposition, Eisenmenger
- •20.Known hypertrophic cardiomyopathy or left ventricular hypertrophy (interventricular septum thickness (IVS) or posterior wall thickness (PWD) >1.2 cm)
- •21.Participation in any clinical drug trial within 4 weeks prior to screening of this study and/or who is scheduled to receive another investigational medicinal product (IMP) during the course of this study
- •22.Pregnancy or lactation
研究者
相似试验
进行中（未招募）
1 期
Frühtherapie der pulmonal arteriellen Hypertonie (PAH)Exercise induced pulmonary hypertension in patients with connective tissue disaesesEUCTR2007-004288-23-ATMedizinische Universität Graz
已完成
2 期
Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Pulmonary HypertensionSystemic SclerosisNCT02290613Heidelberg University38
已完成
不适用
Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseasesPulmonary arterial hypertension (PAH) associated with connective tissue diseaseJPRN-UMIN000001350Keio University70
进行中（未招募）
不适用
Betablocker Therapy in Pulmonary Arterial HypertensioEUCTR2010-020424-21-NLVU medical center
已完成
2 期
Betablocker Therapy in Pulmonary Arterial Hypertensioidiopathische pulmonale hypertensiehigh bloodpressure pulmonary vascular system10019280pulmonary hypertensionNL-OMON34177Vrije Universiteit Medisch Centrum30