High Blood PressureMICRORAHNCT02759276
Microcirculation and Inflammatory Markers in Patients With Resistant, Stages 1/2 Hypertension and Normal Blood Pressure
An observational study of High Blood Pressure, run by Daniel Alexandre Bottino.
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. Read more about this study
- Who is it for?
- Ages 27 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- Autoimmune diseases.
- Infectious processes in activity.
- Neoplasia.
- Aspirin use (anti-inflammatory dose).
- Obesity grade III (Body Mass Index>40 kg/m2).
About this study
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
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.
Read the 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.
- Conditions
- High Blood Pressure
- Keywords
- Nailfold Videocapillaroscopy, Venous Occlusion Plethysmography, Endothelial Function, Microcirculation, Inflammatory Biomarkers
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (mmHg)
Hemodynamic Variable
Measured: 1 day
Secondary outcomes (18)
Functional Capillary Density (FCD, number capillaries/mm2 )
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Afferent Capillary Diameter (micrometer)
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Apical Capillary Diameter (micrometer)
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Efferent Capillary Diameter (micrometer)
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Red Blood Cell Velocity (mm/s)
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Maximum Red Blood Cell Velocity (mm/s)
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Time to reach Maximum Red Blood Cell Velocity (s)
Microcirculatory variable from Nailfold Videocapillaroscopy
Measured: 1 day
Waist circumference (cm)
Anthropometrical Variable
Measured: 1 day
Hip circumference (cm)
Anthropometrical Variable
Measured: 1 day
Waist to Hip Ratio
Anthropometrical Variable
Measured: 1 day
Body Mass Index (Kg/m2)
Anthropometrical Variable
Measured: 1 day
Maximal Forearm Blood Flow during reactive Hyperemia
Vascular Reactivity Variables from Venous Occlusion Plethysmography
Measured: 1 day
Maximal Forearm Blood Flow after sublingual nitroglycerine
Vascular Reactivity Variables from Venous Occlusion Plethysmography
Measured: 1 day
Vascular Cell Adhesion Molecule (VCAM, ng/dl)
Inflammatory Biomarker
Measured: up to 2 weeks
Intercellular Adhesion Molecule (ICAM, ng/dl)
Inflammatory Biomarker
Measured: up to 2 weeks
Adiponectin (ng/dl)
Inflammatory Biomarker
Measured: up to 2 weeks
Endothelin (pg/dl)
Inflammatory Biomarker
Measured: up to 2 weeks
C Reactive Protein (CRP, mg/dl)
Inflammatory Biomarker
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Alexandre Bottino
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State University
- Responsible party
- Sponsor-investigator, Daniel Alexandre Bottino, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759276
- Sponsor's protocol ID
- RiodeJaneiro_StateUniversity
- Other IDs
- BIOVASC-UERJ
- Acronym
- MICRORAH
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02759276
- Acronym / sponsor ID
- MICRORAH / RiodeJaneiro_StateUniversity
- Conditions
- High Blood Pressure
- Keywords
- Nailfold Videocapillaroscopy, Venous Occlusion Plethysmography, Endothelial Function, Microcirculation, Inflammatory Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Daniel Alexandre BottinoUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 27 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Pressure (mmHg)
Time frame: 1 day
Hemodynamic Variable
18 secondary outcomes
Functional Capillary Density (FCD, number capillaries/mm2 )
Time frame: 1 day
Afferent Capillary Diameter (micrometer)
Time frame: 1 day
Apical Capillary Diameter (micrometer)
Time frame: 1 day
Efferent Capillary Diameter (micrometer)
Time frame: 1 day
Red Blood Cell Velocity (mm/s)
Time frame: 1 day
Maximum Red Blood Cell Velocity (mm/s)
Time frame: 1 day
Time to reach Maximum Red Blood Cell Velocity (s)
Time frame: 1 day
Waist circumference (cm)
Time frame: 1 day
Hip circumference (cm)
Time frame: 1 day
Waist to Hip Ratio
Time frame: 1 day
Body Mass Index (Kg/m2)
Time frame: 1 day
Maximal Forearm Blood Flow during reactive Hyperemia
Time frame: 1 day
Maximal Forearm Blood Flow after sublingual nitroglycerine
Time frame: 1 day
Vascular Cell Adhesion Molecule (VCAM, ng/dl)
Time frame: up to 2 weeks
Intercellular Adhesion Molecule (ICAM, ng/dl)
Time frame: up to 2 weeks
Adiponectin (ng/dl)
Time frame: up to 2 weeks
Endothelin (pg/dl)
Time frame: up to 2 weeks
C Reactive Protein (CRP, mg/dl)
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of High Blood Pressure, run by Daniel Alexandre Bottino.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (mmHg) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.