EUCTR2014-004066-20-IT进行中（未招募）1 期
Studio prospettico, multicentrico, a braccio singolo, in aperto, di fase 4 per la valutazione degli effetti del macitentan sul rimodellamento del ventricolo destro nell'ipertensione arteriosa polmonare (Right vEntricular remodeling in Pulmonary ArterIal hypeRtension) accertata mediante risonanza magnetica cardiaca per immagini. - REPAIR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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.Symptomatic PAH.
- •3.World Health Organization (WHO) Functional Class (FC) I to III.
- •4.PAH etiology belonging to one of the following groups according to Nice classification:
- •1.1 Idiopathic PAH
- •1.2 Heritable PAH
- •1.3 Drug- and toxin-induced PAH
- •1.4.4 PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair.
- •5.Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) during screening showing:
- •Mean pulmonary arterial pressure (mPAP) = 25 mmHg and
- •oPulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) = 12 mmHg and pulmonary vascular resistance (PVR) = 4 Woods Units (WU) (320 dyn.sec.cm-5) or
- •o12 mmHg = PCWP or LVEDP = 15 mmHg and PVR = 6 WU (480 dyn.sec.cm-5).
- •6.6-minute walk distance (6MWD) = 150 m during screening.
- •7.For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period.
- •8.For patients treated with phosphodiesterase type-5 (PDE-5) inhibitors, treatment dose must have been stable at least 3 months prior to RHC during the screening period.
- •9.For patients treated with beta blockers, treatment dose must have been stable at least 1 month prior to the RHC during the screening period.
- •10.Men or women = 18 and < 65 years.
- •11.Women of childbearing potential [see Section 4.5.1] must:
- •a.Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
- •b.Agree to use reliable methods of contraception [see Section 4.5] from screening up to 30 days after study treatment discontinuation, and
- •Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation.
- •b.Agree to use reliable methods of contraception [see Section 4.5] from screening up to 30 days after study treatment discontinuation, and
- •c.Agree to perform monthly pregnancy tests up to 30 days after study treatment 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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Body weight < 40 kg.
- •2.Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI < 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
- •3.Pregnancy, breastfeeding, or intention to become pregnant during the study.
- •4.Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program.
- •5.Known concomitant life-threatening disease with a life expectancy < 12 months.
- •6.Any condition likely to affect protocol or treatment compliance.
- •7.Hospitalization for PAH within 3 months prior to informed consent signature.
- •8.Left atrial volume indexed for body surface area = 43mL/m2 by echocardiography or cardiac MRI.
- •9.Valvular disease grade 2 or higher.
- •10.History of pulmonary embolism or deep vein thrombosis.
- •11.Documented moderate to severe chronic obstructive pulmonary disease.
- •12.Documented moderate to severe restrictive lung disease.
- •13.Historical evidence of significant coronary artery disease established by:
- •oHistory of myocardial infarction or
- •oMore than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
- •oElevation of the ST segment on electrocardiogram or
- •oHistory of coronary artery bypass grafting or
- •oStable angina.
- •14.Diabetes mellitus.
- •15.Moderate to severe renal insufficiency (calculated creatinine clearance < 60 mL/min/1.73 m2).
- •16.Cancer.
- •17.Systolic blood pressure < 90 mmHg.
- •18.Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by an aspartate aminotransferase (AST) elevation > ULN at screening.
- •19.Hemoglobin < 100g/L.
- •20.Serum AST and/or alanine aminotransferase (ALT) > 3 × ULN.
- •21.Need for dialysis.
- •22.Responders to acute vasoreactivity test based on medical history.
- •23.Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues.
- •24.Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John’s Wort).
- •25.Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir).
- •26.Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
- •27.Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya).
- •28.Claustrophobia.
- •29.Permanent cardiac pacemaker, automatic internal cardioverter.
- •30.Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device).
- •31.Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
- •32.For patients enrolling in the metabolism sub-study only: glucose intolerance.
- •33.For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital he
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