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临床试验/NCT01743911
NCT01743911已完成不适用

Phosphodiesterase-5 Inhibitor (Tadalafil) Two Weeks Administration Period Effects in Left Ventricle Diastolic Dysfunction and BNP Levels in Resistant Hypertensive Patients

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Change in Left Ventricle Diastolic Dysfunction

研究概览

简要总结

Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic function in hypertensive rats, despite any difference in blood pressure levels. Also, left ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients. However, it is unknown if these effects exists in humans with resistant hypertension. Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil) for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.

详细描述

Resistant hypertensive patients have a high incidence of left ventricle diastolic dysfunction (LVDD). Lowering blood pressure levels improves diastolic function, however, there is no proved effective treatment specifically for this disease. Studies in hypertensive rats have shown presence of phosphodiesterase-5 in cardiac cells and an improvement in left ventricle diastolic function using a phosphodiesterase-5 (PDE5) inhibitor, the sildenafil. PDE5 has also been demonstrated in human heart cells with cardiac disease. In addition, LVDD is associated with high levels of brain natriuretic peptide (BNP), which reduces with diastolic function improvement. Therefore, it is reasonable to suppose that PDE-5 inhibitor use in humans with LVDD and resistant hypertension could improve diastolic function. Objective: Evaluate the chronic effect of a PDE-5 inhibitor on LVDD and BNP levels in resistant hypertensive patients. Casuistic and methods: 20 resistant hypertensive patients with LVDD types I and II will be evaluated with echocardiography study, ambulatory blood pressure monitoring (ABPM), office blood pressure measurements, endothelial function analysis using the brachial artery flow mediation dilation technique (FMD) and BNP plasma levels. Then, the subjects will receive oral placebo for 2 weeks. After this period, the same exams will be repeated. Two weeks later, the protocol will be performed again to the same 20 patients, using tadalafil (the longest half-life PDE-5 inhibitor) 20mg orally instead of the placebo. Hypothesis: investigators hypothesize that the use of tadalafil will improve left ventricle diastolic function with BNP reduced levels and this effect will be independent of blood pressure decrease or endothelial function improvement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • resistant hypertension (according to Resistant Hypertension - American Heart Association Statement - 2008);
  • compliance with antihypertensive treatment;
  • age >35 years;
  • left ventricle diastolic dysfunction types I and II

排除标准

  • valvulopathy
  • decompensated heart failure
  • important cardiac arrhythmias
  • nephropathy
  • hepatopathy
  • autoimmune disease
  • decompensated diabetes
  • uncontrolled dislipidemia

研究组 & 干预措施

sugar pill

Placebo Comparator

Intervention: sugar pill

干预措施: sugar pill (Other)

tadalafil

Active Comparator

Intervention: tadalafil

干预措施: Tadalafil (Drug)

结局指标

主要结局

Change in Left Ventricle Diastolic Dysfunction

时间窗: Baseline and 2 weeks

Outcome measurement assessed by Echocardiogram before and after a 2-week tadalafil administration period.

次要结局

  • Change in endothelial function(baseline and 2 weeks)
  • Change in blood pressure levels(Baseline and 2 weeks)
  • Change in B-type Natriuretic Peptide (BNP-32) levels(Baseline and 2 weeks)
  • Change in cyclic guanosine monophosphate (cGMP) levels(Baseline and 2 weeks)
  • Change in nitrite levels(Baseline and 2 weeks)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heitor Moreno Junior

MD, PhD.

University of Campinas, Brazil

研究点 (1)

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