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
2 other identifiers
observational
75
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedMay 3, 2016
April 1, 2016
7 months
April 20, 2016
April 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Pressure (mmHg)
Hemodynamic Variable
1 day
Secondary Outcomes (18)
Functional Capillary Density (FCD, number capillaries/mm2 )
1 day
Afferent Capillary Diameter (micrometer)
1 day
Apical Capillary Diameter (micrometer)
1 day
Efferent Capillary Diameter (micrometer)
1 day
Red Blood Cell Velocity (mm/s)
1 day
- +13 more secondary outcomes
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniel Alexandre Bottinolead
- Rio de Janeiro State Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., PhD
Study Record Dates
First Submitted
April 20, 2016
First Posted
May 3, 2016
Study Start
May 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 3, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share