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

29. april 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

75

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

27 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood Pressure (mmHg)
Tidsramme: 1 day
Hemodynamic Variable
1 day

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Daniel Alexandre Bottino

Samarbejdspartnere

Rio de Janeiro State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

20. april 2016

Først indsendt, der opfyldte QC-kriterier

29. april 2016

Først opslået (Skøn)

3. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RiodeJaneiro_StateUniversity
  • BIOVASC-UERJ (Anden identifikator: Clinical and Experimental Research Lab on Vascular Biology)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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