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

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil (Other)
• Overall Status: Completed
• CT.gov ID: NCT03243045
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 34.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension; Resistant Arterial Hypertension	Procedure: Renal sympathetic denervation

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of Systemic Microvascular Density and Endothelial Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Jan 6, 2020
• Actual Study Completion Date: Jan 6, 2020

Outcome Measures

Primary Outcome Measures

1. Cutaneous microvascular reactivity [Before and one, three, six and twelve months after intervention]

   Evaluation of microvascular reactivity using laser speckle contrast imaging

2. Cutaneous microvascular flow [Before and one, three, six and twelve months after intervention]

   Evaluation of the microvascular flow using laser speckle contrast imaging

Secondary Outcome Measures

1. Cutaneous capillary density [Before and one, three, six and twelve months after intervention]

   Evaluation of cutaneous capillary density and reactivity using video-capillaroscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Resistant arterial hypertension under pharmacological treatment

Exclusion Criteria:

• secondary arterial hypertension

• renal dysfunction

• severe kidney disease

• congestive heart failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cardiology	Rio de Janeiro		Brazil	21040-360

Sponsors and Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eduardo Tibirica, MD, PhD, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
• ClinicalTrials.gov Identifier: NCT03243045
• Other Study ID Numbers: CAAE-51310815.0.0000.5272
• First Posted: Aug 8, 2017
• Last Update Posted: Jan 7, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eduardo Tibirica, MD, PhD, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil: Arterial hypertension; Microcirculation; Sympathetic nervous system
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jan 7, 2020