NL-OMON52455已完成4 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) - RESTORE
Actelion Pharmaceuticals0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
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
- 18 至 64（—）
入选标准
- •1.Signed informed consent prior to any study-mandated procedure
- •2.WHO FC II or III. Enrollment will be stratified by WHO FC II or III.
- •Proportion of participants with WHO FC II and WHO FC III are expected to be
- •approximately 40% and 60% respectively.
- •3.PAH etiology belonging to one of the following groups according to
- •classification:
- •Idiopathic PAH
- •Heritable PAH
- •Drugs or toxins induced
- •PAH associated with connective tissue disease
- •PAH associated with congenital heart disease, with simple
- •systemic-topulmonary 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
- •PVR >5 WU (400 dyn.s.cm-5) and
- •RVSV <= 60 mL as shown in RHC (CO/HR)
- •5. Patients already receiving PAH-specific oral mono or dual therapy (ie,
- •phosphodiesterase type 5 inhibitors (PDE-5i) or soluble guanylate cyclase
- •stimulators (sGCs) and/or ERA) or patients who are not candidates for these
- •therapies. If on oral PAH-specific therapy, treatment has to be stable (ie, no
- •introduction of new therapies or changes in dose) for at least 90 days prior to
- •both ICF signature and Day 1
- •6.NT-proBNP >=300 ng/L at screening
- •7.Men or women >=18 years (or the legal age of consent in the jurisdiction in
- •which the study is taking place if greater than 18) and <65 years
- •8.Women of childbearing potential (Section 10.5) must meet the following
- •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 to at least 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 to at least 30 days after study
- •intervention discontinuation
- •9. 6MWD >=150 m during screening period
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 or body weight <40 kg
- •11.Presence of one or more of the following signs of relevant lung disease at
- •any time up to Day 1 - 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. Known and documented moderate or severe hepatic impairment (with or without
- •cirrhosis) at screening, defined as Child-Pugh Class 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 preexisting
- •conditions that did not worsen)
- •19.Concomitant life-threatening disease with a life expectancy of less than 12
- •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.Pregnancy, breastfeeding, or intention to become pregnant during the study.
- •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
- 另有 4 项未显示
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