NCT03243045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

August 3, 2017

Last Update Submit

January 6, 2020

Conditions

Arterial HypertensionResistant Arterial Hypertension

Keywords

Arterial hypertensionMicrocirculationSympathetic nervous system

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Cutaneous capillary density

    Before and one, three, six and twelve months after intervention

Interventions

Renal sympathetic denervationPROCEDURE

Transcutaneous renal sympathetic denervation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Resistant arterial hypertension under pharmacological treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • EDUARDO V TIBIRICA, MD, PhD

    National Innstitute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

March 1, 2017

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

BR(1)