NCT07483177招募中1 期
Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Carotid-femoral pulse wave velocity (cfPWV)
研究概览
简要总结
The purpose of this study is to determine whether spironolactone reduces aortic stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), compared with placebo, in patients with degenerative thoracic aortic aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years old with dTAA of the aortic root and/or ascending aorta exceeding the upper limit of normal for age, sex, and body surface area (≥ 4.0 cm as an example of a common threshold; but age, sex and body size-specific thresholds have been established for the aortic root24 and ascending aorta25);
- •no antihypertensive use or stable antihypertensive regimen ≥ 4 weeks;
- •eGFR ≥ 50 mL/min/1.73 m²;
- •serum potassium ≤ 5.1 mmol/L;
- •ability to provide informed consent.
排除标准
- •Heritable aortopathies (Marfan, Loeys-Dietz, vascular Ehlers-Danlos, Turner syndromes; familial TAA, genetically-proven TAA);
- •bicuspid aortic valve;
- •inflammatory aortitis,
- •prior aortic surgery, endovascular repair, or acute aortic syndrome;
- •permanent atrial fibrillation/flutter;
- •major peripheral artery disease affecting the carotids, iliacs and/or external femoral arteries precluding cfPWV measurement;
- •current use of spironolactone, eplerenone or finererone;
- •pregnancy or lactation.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Spironolactone
Experimental
干预措施: Spironolactone (Drug)
结局指标
主要结局
Change in Carotid-femoral pulse wave velocity (cfPWV)
时间窗: Baseline, 6 months
Carotid-femoral pulse wave velocity will be calculated by (Distance/Pulse Transit Time) and reported as m/s
次要结局
- Changes in central blood pressure(Baseline, 6 months)
- Aortic characteristic impedance(Baseline, 6 months)
- Total and proximal arterial compliance(Baseline, 6 months)
- Indices of wave reflection(Baseline, 6 months)
研究者
Thais Coutinho
Principal Investigator
Mayo Clinic
研究点 (1)
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