Systemic Microvascular Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation

January 6, 2020 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Evaluation of Systemic Microvascular Density and Endothelial Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation

It has been proposed that the modulation of the activity of the sympathetic nervous system, through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation.

The present study aimed to investigate the influence of the renal sympathetic denervation on the skin microvascular function of patients presenting with resistant arterial hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Arterial hypertension is still a serious public health problem with considerable social and economic impact. Arterial hypertension is the result from a complex interaction between environmental and genetic factors that initiate and perpetuate elevated blood pressure. Studies show that about 10% of patients undergoing treatment have resistant hypertension, defined as high blood pressure refractory to at least three antihypertensive drugs. It is known that the sympathetic nervous system plays a fundamental role in the pathophysiology of hypertension, contributing to metabolic and vascular changes. The sympathetic nervous system has also a major role in the pathophysiology of arterial hypertension. Arterial hypertension has also been associated with functional microcirculatory alterations as well as systemic microvascular endothelial dysfunction in hypertensive patients, confirmed by different microcirculatory flowmetry techniques. In this context, it has been proposed that the modulation of the sympathetic nervous system through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation.

The present study aimed to investigate the influence of the renal sympathetic denervation on the skin microvascular function of patients with resistant hypertension.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with a confirmed diagnosis of resistant arterial hypertension who were admitted to the National Institute of Cardiology (NIC) at the Ministry of Health in Rio de Janeiro, Brazil. The NIC is a national reference center for the treatment and research of cardiovascular diseases.

Description

Inclusion Criteria:

  • Resistant arterial hypertension under pharmacological treatment

Exclusion Criteria:

  • secondary arterial hypertension
  • renal dysfunction
  • severe kidney disease
  • congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous microvascular reactivity
Time Frame: Before and one, three, six and twelve months after intervention
Evaluation of microvascular reactivity using laser speckle contrast imaging
Before and one, three, six and twelve months after intervention
Cutaneous microvascular flow
Time Frame: Before and one, three, six and twelve months after intervention
Evaluation of the microvascular flow using laser speckle contrast imaging
Before and one, three, six and twelve months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous capillary density
Time Frame: Before and one, three, six and twelve months after intervention
Evaluation of cutaneous capillary density and reactivity using video-capillaroscopy
Before and one, three, six and twelve months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Investigators

  • Principal Investigator: EDUARDO V TIBIRICA, MD, PhD, National Innstitute of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

January 6, 2020

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE-51310815.0.0000.5272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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