NCT02759276

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

April 20, 2016

Last Update Submit

April 29, 2016

Conditions

Keywords

Nailfold VideocapillaroscopyVenous Occlusion PlethysmographyEndothelial FunctionMicrocirculationInflammatory Biomarkers

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

Age27 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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