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OpenTrials
Completed

NCT Number: NCT03243045

Systemic Microvascular 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resistant arterial hypertension under pharmacological treatment

Exclusion criteria

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

Treatment and study plan

Renal sympathetic denervation

Procedure

Transcutaneous renal sympathetic denervation

Primary outcomes

  1. Cutaneous microvascular reactivity

    Time frame: Before and one, three, six and twelve months after intervention

    Evaluation of microvascular reactivity using laser speckle contrast imaging

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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