Systemic Microvascular Function in Patients With Resistan... | NCT03243045

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

NCT03243045

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Status

Completed

Last Update Posted

Jan 7, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Arterial Hypertension
Resistant Arterial Hypertension

Interventions

Renal sympathetic denervation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jan 6, 2020Actual

Completion Date

Jan 6, 2020Actual

First Submitted Date

Aug 3, 2017

First Submission Date that Met QC Criteria

Aug 7, 2017

First Posted Date

Aug 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2020

Last Update Posted Date

Jan 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eduardo Tibirica, MD, PhD, MD, PhD, National Institute of Cardiology, Laranjeiras, BrazilPrincipal Investigator

Lead Sponsor

National Institute of Cardiology, Laranjeiras, BrazilOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal sympathetic denervation	Procedure	Transcutaneous renal sympathetic denervation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Resistant arterial hypertension under pharmacological treatment

Exclusion Criteria:

secondary arterial hypertension
renal dysfunction
severe kidney disease
congestive heart failure

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
EDUARDO V TIBIRICA, MD, PhD	National Innstitute of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Cardiology		Rio de Janeiro		21040-360	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided