EUCTR2019-004783-22-NL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 clinical trial of medicinal product
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. 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-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 >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 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 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
- •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 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 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 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.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 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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