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Completed

NCT Number: NCT02759276

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

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.

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Key information

Age range

27 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Blood Pressure (mmHg)

    Time frame: 1 day

    Hemodynamic Variable

Secondary outcomes

  1. Functional Capillary Density (FCD, number capillaries/mm2 )

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  2. Afferent Capillary Diameter (micrometer)

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  3. Apical Capillary Diameter (micrometer)

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  4. Efferent Capillary Diameter (micrometer)

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  5. Red Blood Cell Velocity (mm/s)

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  6. Maximum Red Blood Cell Velocity (mm/s)

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  7. Time to reach Maximum Red Blood Cell Velocity (s)

    Time frame: 1 day

    Microcirculatory variable from Nailfold Videocapillaroscopy

  8. Waist circumference (cm)

    Time frame: 1 day

    Anthropometrical Variable

  9. Hip circumference (cm)

    Time frame: 1 day

    Anthropometrical Variable

  10. Waist to Hip Ratio

    Time frame: 1 day

    Anthropometrical Variable

  11. Body Mass Index (Kg/m2)

    Time frame: 1 day

    Anthropometrical Variable

  12. Maximal Forearm Blood Flow during reactive Hyperemia

    Time frame: 1 day

    Vascular Reactivity Variables from Venous Occlusion Plethysmography

  13. Maximal Forearm Blood Flow after sublingual nitroglycerine

    Time frame: 1 day

    Vascular Reactivity Variables from Venous Occlusion Plethysmography

  14. Vascular Cell Adhesion Molecule (VCAM, ng/dl)

    Time frame: up to 2 weeks

    Inflammatory Biomarker

  15. Intercellular Adhesion Molecule (ICAM, ng/dl)

    Time frame: up to 2 weeks

    Inflammatory Biomarker

  16. Adiponectin (ng/dl)

    Time frame: up to 2 weeks

    Inflammatory Biomarker

  17. Endothelin (pg/dl)

    Time frame: up to 2 weeks

    Inflammatory Biomarker

  18. C Reactive Protein (CRP, mg/dl)

    Time frame: up to 2 weeks

    Inflammatory Biomarker

Sponsors and collaborators

Lead sponsor

Daniel Alexandre Bottino

Other

Collaborators

  • Rio de Janeiro State University

Registry information

Official study 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

Acronym: MICRORAH

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 3, 2016
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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