EUCTR2018-004828-11-FR进行中（未招募）1 期
Phosphodiesterase-type 5 inhibitors in adult and adolescent patients with univentricular heart disease: a multi-center, randomized, double blind phase III study - VU-Inhibition
niversity Hospital of Montpellier0 个研究点目标入组 50 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •1.15 years of age and over.
- •2.Patient’s weight over 20 kg
- •3.Patients with CHD with a single ventricular type defined by the classification of congenital heart diseases in Orphanet [50].
- •4.PAH defined by diagnostic catheterization with mean PAP > 15 mmHg and a trans-pulmonary gradient > 5 mmHg, performed as part of the usual follow-up. No definition of PAH in SV is available as a result of a particular physiology. Therefore, we chose the 15mmHg cut-off, which is used in clinical routine to allow or contra-indicate the Fontan procedure [50,51].
- •5.Appropriate written informed consent (adult patients, legal parents for teenagers), and formal assent (teenagers), should to be provided.
- •6.Beneficiary of a health insurance.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient who is unable to perform a cardio-pulmonary exercise test.
- •2.Cardiac surgery planned during the trial.
- •3.Patient treated by any pulmonary arterial vasodilator drug, as defined in the 2015 PH guidelines [49], within 6 months before inclusion, regardless the duration and the type(s) (oral, intravenous, subcutaneous, inhaled) of administration.
- •4.Patient treated by Sildenafil or any other type of phosphodiesterase--type 5 inhibitor (such as tadalafil) within 6 months before inclusion, regardless the duration of administration.
- •5.Interventional cardiac catheterization planned during the trial (collateral occlusion, fenestration occlusion, stenting, angioplasty, ablation of rhythm disorder), other than during the screening.
- •6.Participation in another clinical trial or administration of an off-label drug in the 4 weeks preceding the screening.
- •7.Pregnancy, desire for pregnancy, absence of contraception during the study period.
- •8.Severe hepatic insufficiency (Child-Pugh C class).
- •9.Hypersensitivity to the active substance or to any of the excipients of the tablet: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, stearate of magnesium, hypromellose, titanium dioxide (E171), monohydrate lactose, glycerol triacetate.
- •10.Combination with products called nitric oxide donors (such as amyl nitrite) or with nitrates in any form, due to the hypotensive effects of nitrates.
- •11.Concomitant administration of PDE5 inhibitors, such as Sildenafil, with guanylate cyclase stimulators, such as Riociguat.
- •12.Combination with the most potent inhibitors of CYP3A4 (eg ketoconazole, itraconazole, ritonavir)
- •13.Disposition to priapism, sclerosis of corpora cavernosa, disease of La Peyronie, sickle cell anemia, multiple myeloma, leukemia.
- •14.Uncontrolled hypotension or risk of hypotension: water depletion, obstruction to ejection of the left ventricle, dysfunction of the autonomic nervous system, patient under alpha-blocker.
- •15.Severe cardiovascular events, recent (<3 months) or not stabilized: myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage.
- •16.Active hemorrhagic disorders.
- •17.Active gastro-duodenal ulcer.
研究者
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