EUCTR2019-002873-80-ES进行中（未招募）1 期
nicentre, open, uncontrolled clinical trial to assess the morphological, biochemical and functional effects of Diflunisal treatment in patients with transthyretin cardiac amyloidosis
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE0 个研究点目标入组 20 人开始时间: 2019年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •1. Patients over 18 years old
- •2. Diagnosed of cardiac amyloidosis by TTR by cardiac uptake grade 2 or 3 in a scintigraphy performed with Tc-DPD in the absence of monoclonal scintigraphy or by myocardial biopsy with positive immunofixation in the case of presenting peripheral blood gamma pathia.
- •3. Acceptance and signing of consent for the study after receiving the appropriate information.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Known allergy or hypersensitivity to diflunisal or any of its components, or to drugs from the group of non-steroidal anti-inflammatory drugs.
- •2. History of acute episodes of asthma, hives, rhinitis or angioedema in relation to ibuprofen, aspirin or other NSAIDs.
- •3. History or active episode of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
- •4. Severe heart failure (NYHA functional class IV)
- •5. Severe renal impairment: Glomerular filtration estimated <30mL / min / 1.73 m2 calculated by the CKD-EPI formula.
- •6. Survival <1 year due to some known comorbidity
- •7. Concomintant treatment with 2 antiplatelet agents associated with 1 anticoagulant
- •8. Previous liver or heart transplantation
- •9. Hepatic dysfunction (ALT / AST or BT above 3 times the upper limit of normal)
- •10. Platelets <100,000 / mm3
- •11. Potentially fertile women who are not willing to use a contraceptive method that is considered effective
- •12. Pregnancy or breastfeeding
- •13. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment.
- •14. At the discretion of the investigator, the patient's inability to understand or comply with the study procedures
研究者
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