Clinical trial NCT03243045: Systemic Microvascular Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
Official title: Evaluation of Systemic Microvascular Density and Endothelial Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Resistant Arterial Hypertension
Keywords: Arterial hypertension
Microcirculation
Sympathetic nervous system
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2017-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Resistant arterial hypertension under pharmacological treatment

Exclusion Criteria:

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

Primary outcomes:
measure: Cutaneous microvascular reactivity
timeFrame: Before and one, three, six and twelve months after intervention
measure: Cutaneous microvascular flow
timeFrame: Before and one, three, six and twelve months after intervention
Secondary outcomes:
measure: Cutaneous capillary density
timeFrame: Before and one, three, six and twelve months after intervention
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology
Study officials:
affiliation: National Innstitute of Cardiology
name: EDUARDO V TIBIRICA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: