EUCTR2019-004783-22-FR进行中（未招募）1 期
A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE
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
- 80
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
- 性别
- All
入选标准
- •1.Signed informed consent prior to any study-mandated procedure
- •2.WHO FC II or III
- •3.PAH etiology belonging to one of the following groups according to classification:
- •Idiopathic PAH
- •Heritable PAH
- •PAH associated with connective tissue disease
- •PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
- •4.First hemodynamic diagnosis of PAH by right heart catheterization (RHC) within 12 months prior to initiation of selexipag, showing:
- •mPAP =25 mmHg and
- •PA wedge pressure (PAWP) or LV end-diastolic pressure =15 mmHg and
- •PVR >3 WU (240 dyn.s.cm-5)
- •5.For participants already receiving PAH-specific therapy, the PAH treatment dose must have been stable for at least 3 months before informed consent form (ICF) signature, and until Day 1
- •6.NT-proBNP >300 ng/mL at screening
- •7.Men or women =18 and <65 years
- •8.Women of childbearing potential (Section 10.5) must meet the following criteria:
- •Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
- •Agree to use reliable methods of contraception from Day 1 up to 30 days after study intervention discontinuation (Section 10.5), and
- •If only using hormonal contraception, have used it for at least 1 month (30 days) before Day 1, and
- •Agree to perform monthly pregnancy tests up to 30 days after study intervention discontinuation
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior use of IP-receptor agonist, prostacyclin, or prostacyclin analog. Use of such treatments for vasoreactivity testing is not exclusionary; intermittent use of such treatments for digital ulcers or Raynaud’s phenomenon is not exclusionary if stopped >6 months (180 days) prior to Day 1
- •2.Treatment with strong inhibitors of CYP2C8 (eg, gemfibrozil) within 28 days prior to Day 1
- •3.Treatment with another investigational drug planned or taken within 12 weeks (84 days) prior to Day 1
- •4.Cardiopulmonary rehabilitation programs based on exercise between informed consent and expected Week 26 visit date
- •5.Decompensated cardiac failure requiring hospitalization, emergency room visit or intravenous diuretics in the 6 weeks before informed consent
- •6.Severe coronary heart disease or unstable angina
- •7.Cerebrovascular events (eg, transient ischemic attack, stroke) within 3 months prior to Day 1
- •8.Left atrial volume indexed for body surface area =43 mL/m2, assessed by Echo or cardiac MRI
- •9.Myocardial infarction within 6 months prior to Day 1
- •10.Body mass index >40 kg/m2
- •11.Presence of one or more of the following signs of relevant lung disease at any time up to screening - if pulmonary function test results are missing, then exclusion 11 is considered as met
- •Diffusing capacity of the lung for carbon monoxide <40% of predicted UNLESS computed tomography reveals no or mild interstitial lung disease
- •Forced vital capacity <60% of predicted
- •Forced expiratory volume in 1 second <60% of predicted
- •12.Known or suspected pulmonary veno-occlusive disease (PVOD)
- •13.Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
- •14.SBP <90 mmHg at screening or on Day 1
- •15.Severe renal impairment (estimated creatinine clearance =30 mL/min/1.73 m2 or serum creatinine >2.5 mg/dL at screening) or ongoing or planned dialysis
- •16.Documented moderate or severe hepatic impairment (with or without cirrhosis) at screening, defined as Child-Pugh Class B or C
- •17.Known or suspected uncontrolled thyroid disease (hypo- or hyperthyroidism)
- •18.Any hospitalization within 6 weeks prior to informed consent (except elective hospitalizations for surgery or standard monitoring of pre-existing conditions that did not worsen)
- •19.Concomitant life-threatening disease with a life expectancy of less than 12 months
- •20.Hemoglobin <80 g/L at screening
- •21.Hypersensitivity to selexipag or any study intervention excipient (mannitol, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, propylene glycol, titanium dioxide, carnauba wax, iron oxide red, iron oxide yellow, iron oxide black)
- •22.Breastfeeding
- •23.Any factor or condition likely to affect compliance with study intervention or visit plan, as judged by the investigator
- •24.Claustrophobia
- •25.MRI-incompatible permanent cardiac pacemaker, automatic internal cardioverter
- •26.Metallic implant (eg, defibrillator, neurostimulator, hearing aid, permanent use of infusion device, dental brace, metal-containing tattoo ink)
- •27.Severe arrythmia, atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI
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