Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Recruiting

• Conditions: Resistant Hypertension; Microvascular Rarefaction; Endothelial Dysfunction; Arterial Hypertension
• Interventions: Diagnostic Test: Evaluation of systemic skin microvascular endothelial function

• Registration Number: NCT05464849
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resistant hypertension	Evaluation of systemic skin microvascular endothelial function	Patients presenting with resistant hypertension
non-resistant hypertension	Evaluation of systemic skin microvascular endothelial function	Patients presenting with non-resistant hypertension
normotensive subjects	Evaluation of systemic skin microvascular endothelial function	control group including normotensive volunteers

Primary Outcome Measures

Name	Time	Method
Systemic microvascular reactivity	two years - during one visit to the microcirculation laboratory	evaluation of endothelium-dependent and -independent microvascular function

Trial Locations

Locations (1)

Eduardo Tibiriçá; 🇧🇷 Rio de Janeiro, Brazil