Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Conditions
-----------------
Arterial Hypertension, Resistant Hypertension, Microvascular Rarefaction, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Evaluation of systemic skin microvascular endothelial function


Participation Criteria
=================
Eligibility Criteria
-----------------
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 .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resistant hypertension<br>Patients presenting with resistant hypertension | Diagnostic Test: Evaluation of systemic skin microvascular endothelial function<br>* 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.<br>|
| non-resistant hypertension<br>Patients presenting with non-resistant hypertension | Diagnostic Test: Evaluation of systemic skin microvascular endothelial function<br>* 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.<br>|
| normotensive subjects<br>control group including normotensive volunteers | Diagnostic Test: Evaluation of systemic skin microvascular endothelial function<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic microvascular reactivity | evaluation of endothelium-dependent and -independent microvascular function | two years - during one visit to the microcirculation laboratory |