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

High Blood Pressure Clinical Trial

— MICRORAH  

Official title:

Inflammatory Biomarkers and Endothelial Function Assessed by Venous Occlusion Plethysmography and Nailfold Videocapillaroscopy in Patients With Resistant Hypertension, Stages 1 and 2 and Normotensive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759276
• Other study ID #: RiodeJaneiro_StateUniversity
• Secondary ID: BIOVASC-UERJ
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: April 29, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 27 Years to 65 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Alexandre Bottino	Rio de Janeiro State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure (mmHg)	Hemodynamic Variable	1 day	No
Secondary	Functional Capillary Density (FCD, number capillaries/mm2 )	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Afferent Capillary Diameter (micrometer)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Apical Capillary Diameter (micrometer)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Efferent Capillary Diameter (micrometer)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Red Blood Cell Velocity (mm/s)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Maximum Red Blood Cell Velocity (mm/s)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Time to reach Maximum Red Blood Cell Velocity (s)	Microcirculatory variable from Nailfold Videocapillaroscopy	1 day	No
Secondary	Waist circumference (cm)	Anthropometrical Variable	1 day	No
Secondary	Hip circumference (cm)	Anthropometrical Variable	1 day	No
Secondary	Waist to Hip Ratio	Anthropometrical Variable	1 day	No
Secondary	Body Mass Index (Kg/m2)	Anthropometrical Variable	1 day	No
Secondary	Maximal Forearm Blood Flow during reactive Hyperemia	Vascular Reactivity Variables from Venous Occlusion Plethysmography	1 day	No
Secondary	Maximal Forearm Blood Flow after sublingual nitroglycerine	Vascular Reactivity Variables from Venous Occlusion Plethysmography	1 day	No
Secondary	Vascular Cell Adhesion Molecule (VCAM, ng/dl)	Inflammatory Biomarker	up to 2 weeks	No
Secondary	Intercellular Adhesion Molecule (ICAM, ng/dl)	Inflammatory Biomarker	up to 2 weeks	No
Secondary	Adiponectin (ng/dl)	Inflammatory Biomarker	up to 2 weeks	No
Secondary	Endothelin (pg/dl)	Inflammatory Biomarker	up to 2 weeks	No
Secondary	C Reactive Protein (CRP, mg/dl)	Inflammatory Biomarker	up to 2 weeks	No