EUCTR2014-004066-20-DE进行中（未招募）1 期
A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension
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
- 87
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
- •The full list of inclusion criteria is provided in Section 4.3 of the Protocol and all patients must fulfill all criteria. The main inclusion criteria are:
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Symptomatic pulmonary arterial hypertension (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
- •1.4.1 PAH associated with connective tissue disease
- •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) performed between Day -28 and Day 1 (inclusion RHC; RHC data obtained at study site within this time frame, prior to obtaining signed informed consent, are acceptable) showing:
- •- mPAP = 25 mmHg and
- •-- PCWP or LVEDP = 12 mmHg and PVR = 4 Wood Units (WU) (320 dyn.sec.cm-5) or
- •--12 mmHg = PCWP or LVEDP = 15 mmHg and PVR = 6WU (480 dyn.sec.cm-5)
- •6. 6-minute walk distance (6MWD) = 150 m during screening
- •7. For patients treated with oral loop diuretics, treatment dose must be stable since at least 1 month prior to RHC
- •8. For patients treated with PDE-5 inhibitors, treatment dose must be stable since at least 3 months prior to RHC (initiation of
- •PDE-5 inhibitors during screening is allowed after all screening assessments have been performed).
- •9. For patients treated with beta blockers, treatment dose must be stable since at least 1 month prior to the RHC
- •10. Men or women =18 and < 75 years. For patients aged = 65 and < 75 years, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
- •11. Women of childbearing potential 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 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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •The full list of exclusion criteria is provided in Section 4.4 of the Protocol and all patients must not fulfill any exclusion criterion. The main exclusion criteria are:
- •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 (exept for diagnosis of PAH) within 3 months prior to informed consent signature
- •8. Left atrial volume indexed for body surface area (BSA) = 43mL/m2 by echocardiography or cardiac MRI
- •9. Moderate to severe left-heart valvular disease
- •10. History of pulmonary embolism or deep vein thrombosis
- •11. Presence of one or more of the following signs of relevant lung disease at any time up to screening:
- •- Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% of predicted (eligible only if no or mild interstitial lung disease on computed tomography).
- •- FVC < 60% of predicted.
- •- Forced expiratory volume in one second (FEV1) < 60% of predicted.
- •12. Moderate to severe restrictive lung disease (i.e., total lung capacity < 60% of predicted value) at any time prior to enrollment.
- •13. Historical evidence of significant coronary artery disease established by:
- •- History of myocardial infarction or
- •- More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
- •- Elevation of the ST segment on electrocardiogram or
- •- History of coronary artery bypass grafting or
- •- Stable angina
- •14. Known uncontrolled diabetes mellitus (in the opinion of the investigator)
- •15. Severe renal insufficiency (calculated creatinine clearance < 30 mL/min)
- •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 × ULN accompanied by an AST elevation > ULN at Screening.
- •19. Hemoglobin < 100g/L
- •20. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of the normal range
- •21. Need for dialysis
- •22. Responders to acute vasoreactivity test based on medical history
- •23. Prior use of endothelin receptor antagonists, stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogs
- •24. Treatment with strong inducers of 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 endothelin receptor antagonist or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc,
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