Microcirculation and Inflammatory Markers in Patients With Resistant, Stages 1/2 Hypertension and Normal Blood Pressure (MICRORAH)
2016年4月29日 更新者：Daniel Alexandre Bottino
Inflammatory Biomarkers and Endothelial Function Assessed by Venous Occlusion Plethysmography and Nailfold Videocapillaroscopy in Patients With Resistant Hypertension, Stages 1 and 2 and Normotensive
Nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and inflammatory biomarkers have been used to study endothelial function in patients with resistant hypertension, stages 1 and 2 hypertension and normotensive.
This was a cross-sectional study.
研究概览
地位
完全的
条件
详细说明
Microcirculation determines peripheral resistance contributing to increased blood pressure.
The nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and biomarkers can be used to evaluate the microcirculation in arterial hypertension (AH).
The objective of this study is to analyze the behavior of serum inflammatory markers and study the microcirculation by nailfold videocapillaroscopy (NVC) and Venous Occlusion Plethysmography in patients with resistant hypertension (RH), with stages 1 and 2 hypertension (MMH ) and normotensive (CG).
A cross-sectional study with 75 patients has been performed: 25 with resistant hypertension (RH), 25 with stages 1 and 2 hypertension (MMH) and 25 normotensive (CG).
All underwent anamnesis, dosage serum markers and conducting NVC, VOP.
Hypertensive patients without statin use and with controlled or uncontrolled blood pressure were also analyzed.
For the statistical analysis were used: Kruskal -Wallis ANOVA, Dunn test and ANCOVA for correction of confusion factors such as age and BMI.
研究类型
观察性的
注册 (实际的)
75
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
27年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
First Day: Full clinical examination was performed, including measurements of at-rest blood pressure, weight and height in order to calculate Body Mass Index (BMI), waist and hip measurements.
Second Day: drawing blood for laboratory analyses, Nailfold Videocapillaroscopy and Venous Occlusion Plethysmography.
描述
Inclusion Criteria:
- Clinical diagnosis of controlled High Blood Pressure stages 1 and 2 (blood pressure levels from 140/90 mmHg to 179/109 mmHg) .
- Resistant Hypertension (uncontrolled hypertension, with values ≥140/90 mmHg, using three or more antihypertensive drugs of different classes, including a diuretic, or controlled hypertension with four or more drugs).
- Normal Blood Pressure.
Exclusion Criteria:
- Diabetes Mellitus, Types 1 or 2.
- Heart Failure.
- Myocardial infarction or stroke with less than three months of the event.
- Chronic kidney disease.
- Use of hormonal or non-hormonal anti-inflammatory drugs.
- Recent trauma (less than three months).
- Autoimmune diseases.
- Infectious processes in activity.
- Neoplasia.
- Aspirin use (anti-inflammatory dose).
- Obesity grade III (Body Mass Index>40 kg/m2).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Resistant Hypertension (RH)
uncontrolled hypertension, with values ≥140/90 mmHg, using three or more antihypertensive drugs of different classes, including a diuretic, or controlled hypertension with four or more drugs.
|
|
Stages 1 and 2 Hypertension (MMH)
According to the VI Brazilian Guidelines of hypertension, with blood pressure levels ranging from 140/90 mmHg to 179/109 mmHg, with up to two antihypertensive drugs of different classes and blood pressure levels controlled in the last two months.
|
|
Normotensive (CG)
Blood Pressure <140/90 mmHg and without comorbidities.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Pressure (mmHg)
大体时间：1 day
|
Hemodynamic Variable
|
1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional Capillary Density (FCD, number capillaries/mm2 )
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Afferent Capillary Diameter (micrometer)
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Apical Capillary Diameter (micrometer)
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Efferent Capillary Diameter (micrometer)
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Red Blood Cell Velocity (mm/s)
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Maximum Red Blood Cell Velocity (mm/s)
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Time to reach Maximum Red Blood Cell Velocity (s)
大体时间：1 day
|
Microcirculatory variable from Nailfold Videocapillaroscopy
|
1 day
|
|
Waist circumference (cm)
大体时间：1 day
|
Anthropometrical Variable
|
1 day
|
|
Hip circumference (cm)
大体时间：1 day
|
Anthropometrical Variable
|
1 day
|
|
Waist to Hip Ratio
大体时间：1 day
|
Anthropometrical Variable
|
1 day
|
|
Body Mass Index (Kg/m2)
大体时间：1 day
|
Anthropometrical Variable
|
1 day
|
|
Maximal Forearm Blood Flow during reactive Hyperemia
大体时间：1 day
|
Vascular Reactivity Variables from Venous Occlusion Plethysmography
|
1 day
|
|
Maximal Forearm Blood Flow after sublingual nitroglycerine
大体时间：1 day
|
Vascular Reactivity Variables from Venous Occlusion Plethysmography
|
1 day
|
|
Vascular Cell Adhesion Molecule (VCAM, ng/dl)
大体时间：up to 2 weeks
|
Inflammatory Biomarker
|
up to 2 weeks
|
|
Intercellular Adhesion Molecule (ICAM, ng/dl)
大体时间：up to 2 weeks
|
Inflammatory Biomarker
|
up to 2 weeks
|
|
Adiponectin (ng/dl)
大体时间：up to 2 weeks
|
Inflammatory Biomarker
|
up to 2 weeks
|
|
Endothelin (pg/dl)
大体时间：up to 2 weeks
|
Inflammatory Biomarker
|
up to 2 weeks
|
|
C Reactive Protein (CRP, mg/dl)
大体时间：up to 2 weeks
|
Inflammatory Biomarker
|
up to 2 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年5月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2016年4月20日
首先提交符合 QC 标准的
2016年4月29日
首次发布 (估计)
2016年5月3日
研究记录更新
最后更新发布 (估计)
2016年5月3日
上次提交的符合 QC 标准的更新
2016年4月29日
最后验证
2016年4月1日
更多信息
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