Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05464849
Collaborator
(none)
150
1
41.4
3.6

Study Details

Study Description

Brief Summary

Systemic arterial hypertension is a serious health problem worldwide. In some cases, it can phenotypically present as resistant arterial hypertension, which consists of blood pressure levels outside the treatment goals in patients using three or more classes of antihypertensive drugs, one of which is preferably a thiazide diuretic. Resistant hypertension contributes to a 47% higher risk of developing cardiovascular events when compared to patients with non-resistant hypertension. It is known that the microcirculation plays a relevant role in the pathophysiology of arterial hypertension. Furthermore, it is known that the cutaneous microvascular network is an adequate model and that it reflects the systemic microcirculation. In this sense, the present research proposes the study of cutaneous capillary density - through high resolution intravital microscopy - and of the endothelium-dependent and independent microvascular vasodilator response - by the speckle laser flowmetry method coupled to a pharmacological system of micro- iontophoresis - in patients diagnosed with resistant hypertension, with the aim of identifying changes in comparison with patients with non-resistant hypertension and normotensive individuals. Additionally, the evaluation of the association between systemic microvascular function and the presence of target organ lesions in this population may indicate that this is a new non-invasive way of stratifying cardiovascular risk in these individuals.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension
Actual Study Start Date :
Dec 20, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Resistant hypertension

Patients presenting with resistant hypertension

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function
Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

non-resistant hypertension

Patients presenting with non-resistant hypertension

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function
Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

normotensive subjects

control group including normotensive volunteers

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function
Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

Outcome Measures

Primary Outcome Measures

  1. Systemic microvascular reactivity [two years - during one visit to the microcirculation laboratory]

    evaluation of endothelium-dependent and -independent microvascular function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Resistant hypertension
Exclusion Criteria:
  • Pregnancy or lactation for all groups.

  • For the control group: endocrine and metabolic diseases, including diabetes mellitus, cardiovascular diseases, including hypertension, autoimmune diseases and cancer.

  • For the resistant arterial hypertension and non-resistant arterial hypertension groups: endocrine diseases, except diabetes mellitus, autoimmune diseases and cancer .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eduardo TibiriƧƔ Rio de Janeiro Brazil 22240006

Sponsors and Collaborators

  • National Institute of Cardiology, Laranjeiras, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eduardo Tibirica, MD, PhD, Senior researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier:
NCT05464849
Other Study ID Numbers:
  • CAAE 53946021.8.0000.5272
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022