CTIS2024-510869-42-00进行中（未招募）1 期
Effect of antifibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burden
niversitaetsmedizin Goettingen0 个研究点目标入组 150 人开始时间: 2024年7月9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
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male, female age = 60, Diagnosis of severe symptomatic aortic stenosis, Transcatheter aortic valve implantation therapy (TAVI) scheduled, Written informed consent
排除标准
- •Pre-existing dilative or ischemic heart disease with EF<35% and guideline indication for spironolactone, Contraindications for Spironolactone (anuria, acute renal failure, serum creatinine > 1.8 mg/dl, hyperkalemia, pregnancy), Contraindications for Dihydralazine (known allergy or hypersensitivity, systemic lupus erythematodes, adrenocortical disorders), Known active malignant disease with life expectancy < 1 year, Women with child-bearing potential, Simultaneous participation (including a waiting period of 4 weeks) in other interventional clinical trials, Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial, Person who is in a relationship of dependence/employment with the sponsor or the investigator, Known planned operations or catheter-based interventions (e.g. PCI, transcatheter edge-to-edge mitral or tricuspid valve repair) during 3 months after study inclusion; the performance of e.g. PCI immediately before study enrolment and before TAVI is possible, Patient on current medication with spironolactone, eplerenone, or dihydralazine, Presence of coexistent myocardial pathology such as cardiac amyloidosis, hypertrophic cardiomyopathy, or myocarditis, Presence of coexistent severe aortic regurgitation or severe mitral stenosis, Previous surgical valve replacement or repair, Pacemaker or ICD implanted, Renal impairment (serum creatinine > 1,8 mg/dl and/ or GFR < 30 ml/min/1,73 m² BSA), Significant hypotension (blood pressure < 90 mm Hg systolic and/or < 50 mm Hg diastolic, Serum potassium > 5,1 mmol/l
研究者
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