Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

NCT05464849 | Completed

• 1 other identifier: CAAE 53946021.8.0000.5272
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistant Hypertension; Microvascular Rarefaction; Endothelial Dysfunction; Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Systemic microvascular reactivity

  evaluation of endothelium-dependent and -independent microvascular function

  two years - during one visit to the microcirculation laboratory

Study Arms (3)

Resistant hypertension

Patients presenting with resistant hypertension

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

non-resistant hypertension

Patients presenting with non-resistant hypertension

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

normotensive subjects

control group including normotensive volunteers

Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

Interventions

Evaluation of systemic skin microvascular endothelial function DIAGNOSTIC_TEST

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.

Resistant hypertension; non-resistant hypertension; normotensive subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Resistant hypertension: 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.

You may qualify if:

• Resistant hypertension

You may not qualify if:

• 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 .

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

Eduardo Tibiriçá

Rio de Janeiro, 22240006, Brazil

Location

Related Publications (1)

• Crahim V, Verri V, De Lorenzo A, Tibirica E. Reduced systemic microvascular function in patients with resistant hypertension and microalbuminuria: an observational study. J Hum Hypertens. 2024 Dec;38(12):806-813. doi: 10.1038/s41371-024-00958-7. Epub 2024 Sep 17.

  PMID: 39289473 DERIVED

MeSH Terms

Conditions

Hypertension; Microvascular Rarefaction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: December 20, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)