2023-503913-31-01招募中3 期
The use of sildenafil in patients with univentricular heart after Fontan operation - a pilot SINFON-POL study.
National Institute Of Cardiology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in peak oxygen uptake (V02max) in ergospirometry test after 24 weeks of treatment
研究概览
简要总结
The main objective of the study is to determine whether, in adult patients with univentricular heart after Fontan operation, in stable clinical condition, without indication for cardiac catheterization, the addition of sildenafil to their existing therapy will result in improved physical performance.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Functionally univentricular heart
- •Post-Fontan operation condition with the creation of a total cavo-pulmonary connection (TCPC) either extracardiac [extracardiac conduit] or intracardiac [lateral intra-atrial tunnel]
- •No clinical indications for cardiac catheterization
- •Age > 18 years
- •Informed consent to participate in the study
排除标准
- •Patients with a functionally univentricular heart within 6 months of their last cardiac operation or intravascular procedure
- •Patients with concomitant diagnoses of: a) cardiovascular events within the last 3 months (acute coronary syndrome, sudden cardiac arrest, ventricular arrhythmias, intracranial hemorrhage, stroke), b) pulmonary embolism, c) infections, d) active bleeding complications, e) severe liver failure (Child-Pugh class C), f) active gastric and/or duodenal peptic ulcer disease, g) malignancy, h) primary muscle and nervous system disease, i) systemic connective tissue disease, j) myocarditis and/or pericarditis, k) predisposition to priapism, sclerosis of the corpus cavernosum or Peyronie's disease, l) sickle cell anemia, leukemia, or multiple myeloma, m) loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), n) enteropathy with protein loss
- •Pregnancy (positive pregnancy test result), planning pregnancy, breastfeeding
- •Non-use of contraception during the study - applies to women of reproductive age
- •Severe central nervous system damage
- •Taking products containing nitric oxide or nitrates in any form (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate, pentaerythritol tetranitrate); use in combination with the most potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
- •Patients who were taking pulmonary arterial dilators (sildenafil, tadalafil, riociguat, bosentan, macitentan, ambrisentan, epoprostenol, iloprost, selixipag) in the 6 month period preceding study entry, regardless of the duration of therapy and route of administration (oral, intravenous, subcutaneous, inhalated)
- •Patients unable to undergo egrospirometric examination
- •Advanced heart failure (NYHA IV)
- •Resting arterial oxygen saturation <85%
- •Chronic kidney disease (creatinine > 150 µmol/l)
- •Liver damage manifested by a twofold increase in transaminases above the norm
- •Uncontrolled hypotension (blood pressure < 90/50 mmHg) or risk of hypotension (dehydration, systemic ventricular outflow tract obstruction, autonomic nervous system dysfunction, patients taking alpha-blockers)
- •Atrial arrhythmia preventing the execution/interpretation of the above-mentioned tests or a life-threatening exercise-induced arrhythmia history
结局指标
主要结局
Increase in peak oxygen uptake (V02max) in ergospirometry test after 24 weeks of treatment
Increase in peak oxygen uptake (V02max) in ergospirometry test after 24 weeks of treatment
次要结局
- Increase in the distance covered in the 6-minute walk test (6MWT)
- Increase in the amount of exercise performed, measured in metabolic equivalents (METS) during cardiopulmonary exercise testing (CPET) after 24 weeks of treatment
- Increase in the absolute value of global longitudinal strain (GLS) in echocardiography after 24 weeks of treatment
- Reduction in serum Nt-proBNP levels after 24 weeks of treatment
- Reduction in fibrosis score on elastography (abdominal ultrasound) after 24 weeks of treatment
- Increase in the quality of life index as assessed by the SF-36 questionnaire after 24 weeks of treatment
研究者
Clinical Research Support Centre Information Desk
Scientific
National Institute Of Cardiology
研究点 (1)
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