Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Endothelial Dysfunction Clinical Trial

Official title:

Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464849
• Other study ID #: CAAE 53946021.8.0000.5272
• Status: Recruiting
• Start date: December 20, 2021
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: EDUARDO TIBIRICA
• Phone: +55-21-99914-6075
• Email: etibi[@]uol.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Arterial Hypertension
• Endothelial Dysfunction
• Hypertension
• Microvascular Rarefaction
• Resistant Hypertension

Intervention

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.

Locations

Country	Name	City	State
Brazil	Eduardo Tibiriçá	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic microvascular reactivity	evaluation of endothelium-dependent and -independent microvascular function	two years - during one visit to the microcirculation laboratory