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临床试验/NCT01295047
NCT01295047已完成4 期

Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial

Cardiff University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

ATENOLOL 75MG FOR 4 WEEKS

干预措施: Atenolol (Drug)

VERAPAMIL

Active Comparator

240MG VERAPAML FOR 4 WEEKS

干预措施: VERAPAMIL (Drug)

PERINDOPRIL

Active Comparator

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)

研究者

申办方类型
Other

研究点 (1)

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