Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- CENTRAL ARTERIAL PRESSURE
研究概览
简要总结
The investigators are looking at the different impacts of atenolol, verapamil and perindopril on large artery and lv function in marfan syndrome. It is a double-blind, randomised cross-over trial.
详细描述
The investigators recruited 21 patients with confirmed diagnosis of Marfan syndrome from two centres. The investigators performed radial artery applanation tonometry and pulse wave analysis to derive central aortic pressure and haemodynamic indexes pre-and post administering Atenolol 75mg, Perindopril 4mg and Verapamil 240mgs each for four weeks with a two week wash-out between medications. All patients underwent detailed functional and anatomical echocardiographic assessments at each visit.
Inclusion criteria were ages 16-60 years with no treatment or β-blocker or other monotherapy only for Marfan syndrome. Patients with previous aortic dissection or aortic surgery, severe valvular regurgitation, aortic diameter at the sinotubular junction ≥ 5.0cm, contraindications to specific drug treatment, e.g. asthma and β-blocker, or those who were pregnant or at risk of pregnancy were excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome
排除标准
- •Previous aortic dissection or aortic surgery
- •Severe valvular regurgitation
- •Aortic diameter at the sinotubular junction ≥ 5.0cm
- •Contraindications to specific drug treatment, e.g. asthma and β-blocker
- •Those who were pregnant or at risk of pregnancy
研究组 & 干预措施
ATENOLOL
ATENOLOL 75MG FOR 4 WEEKS
干预措施: Atenolol (Drug)
VERAPAMIL
240MG VERAPAML FOR 4 WEEKS
干预措施: VERAPAMIL (Drug)
PERINDOPRIL
4MG PERINDOPRIL FOR 4 WEEKS
干预措施: Perindopril (Drug)
结局指标
主要结局
CENTRAL ARTERIAL PRESSURE
时间窗: 18 weeks
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
次要结局
- LARGE ARTERIAL STIFFNESS INDICES(18 WEEKS)
- LV Function(18 WEEKS)
