Microcirculation and Inflammatory Markers in Patients With Resistant, Stages 1/2 Hypertension and Normal Blood Pressure (MICRORAH)

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.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure (mmHg)	Hemodynamic Variable	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capillary Density (FCD, number capillaries/mm2 )	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Afferent Capillary Diameter (micrometer)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Apical Capillary Diameter (micrometer)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Efferent Capillary Diameter (micrometer)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Red Blood Cell Velocity (mm/s)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Maximum Red Blood Cell Velocity (mm/s)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Time to reach Maximum Red Blood Cell Velocity (s)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day
Waist circumference (cm)	Anthropometrical Variable	1 day
Hip circumference (cm)	Anthropometrical Variable	1 day
Waist to Hip Ratio	Anthropometrical Variable	1 day
Body Mass Index (Kg/m2)	Anthropometrical Variable	1 day
Maximal Forearm Blood Flow during reactive Hyperemia	Vascular Reactivity Variables from Venous Occlusion Plethysmography	1 day
Maximal Forearm Blood Flow after sublingual nitroglycerine	Vascular Reactivity Variables from Venous Occlusion Plethysmography	1 day
Vascular Cell Adhesion Molecule (VCAM, ng/dl)	Inflammatory Biomarker	up to 2 weeks
Intercellular Adhesion Molecule (ICAM, ng/dl)	Inflammatory Biomarker	up to 2 weeks
Adiponectin (ng/dl)	Inflammatory Biomarker	up to 2 weeks
Endothelin (pg/dl)	Inflammatory Biomarker	up to 2 weeks
C Reactive Protein (CRP, mg/dl)	Inflammatory Biomarker	up to 2 weeks

Collaborators and Investigators

• Sponsor: Daniel Alexandre Bottino
• Collaborators: Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Endothelial Function; Microcirculation; Inflammatory Biomarkers; Venous Occlusion Plethysmography; Nailfold Videocapillaroscopy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: RiodeJaneiro_StateUniversity; BIOVASC-UERJ (Other Identifier: Clinical and Experimental Research Lab on Vascular Biology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO