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临床试验/NCT01180413
NCT01180413已完成4 期

Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年12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
发起方
入组人数
48
试验地点
1
主要终点
Coronary Flow Reserve

研究概览

简要总结

The purpose of this study is to determine whether add-on of intensive vasodilator therapy can improve the coronary perfusion and reduce the total peripheral resistance in patients with ongoing treatment for essential hypertension.

详细描述

Morphological changes are observed in the microvasculature of patients with essential hypertension. The lumen diameter is reduced in resistance arteries, but with no change in vessel cross-sectional area or wall mass. These structural changes are termed inward eutrophic remodelling and results in an increased wall:lumen ratio, caused by rearrangement of cell matrix and not by hypertrophy of smooth muscle cells in the vascular wall as observed in secondary forms of hypertension. The morphological changes also occur in the coronary arteries and cause a reduction in the ability to increase coronary perfusion as response to increased cardiac work. This is observed as a reduced coronary flow reserve in patients with sustained hypertension.

Two recently published clinical studies associates an increase in media:lumen ratio with an increased risk of cardiovascular events, and it therefore seems beneficial to normalize the vascular structure in patients with essential hypertension. It has previously been demonstrated that reversion of vascular remodelling and thereby normalization of the vascular structure, requires vasodilatation and not just blood pressure reduction, suggesting that patients with essential hypertension can benefit from antihypertensive treatment aimed to induce vasodilatation.

The purpose of this study is to determine whether add-on of intensive vasodilator therapy can improve the coronary perfusion (coronary flow reserve) and reduce the total peripheral resistance in patients with ongoing treatment for essential hypertension. We also aim to investigate whether changes in coronary flow reserve correlates better to changes in total peripheral resistance than changes in blood pressure. Particularly we aim to study if patients with high total peripheral resistance, despite blood pressure control, can benefit from intensive vasodilating therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ongoing antihypertensive treatment for >3 months
  • Blood pressure >120/75 during antihypertensive treatment
  • Ejection fraction > 45%

排除标准

  • Blood pressure >160/100
  • Pregnancy
  • fertile women not using safe contraceptives
  • known secondary hypertension
  • valvular disease of haemodynamic significance
  • known endocrine disease, nephropathy or hepatic disease
  • present malignant disease
  • known psychiatric disease
  • abnormal lab tests of clinical significance
  • known allergy to any study medication
  • body mass index > 35
  • Ongoing antihypertensive treatment with a combination of ACE-inhibitor and Calcium antagonist.

研究组 & 干预措施

Vasodilatory

Experimental

Patients in this arm will receive intensive vasodilatory treatment

干预措施: Amlodipine (Drug)

Vasodilatory

Experimental

Patients in this arm will receive intensive vasodilatory treatment

干预措施: Ramipril (Drug)

Vasodilatory

Experimental

Patients in this arm will receive intensive vasodilatory treatment

干预措施: Lercanidipine (Drug)

Vasodilatory

Experimental

Patients in this arm will receive intensive vasodilatory treatment

干预措施: Losartan (Drug)

结局指标

主要结局

Coronary Flow Reserve

时间窗: 6 months

Determined by echocardiography

次要结局

  • Blood Pressure(6 months)
  • Left ventricular mass(6 months)
  • Puls Wave Velocity(6 months)
  • Peripheral Vascular Resistance(6 months)
  • Minimal forearm vascular resistance(6 months)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Morten Engholm Pedersen

MD/PhD-Student

Aarhus University Hospital

研究点 (1)

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