Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension

NCT ID: NCT05464849

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Hypertension Resistant Hypertension Microvascular Rarefaction Endothelial Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resistant hypertension

Patients presenting with resistant hypertension

Evaluation of systemic skin microvascular endothelial function

Intervention Type 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.

non-resistant hypertension

Patients presenting with non-resistant hypertension

Evaluation of systemic skin microvascular endothelial function

Intervention Type 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.

normotensive subjects

control group including normotensive volunteers

Evaluation of systemic skin microvascular endothelial function

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eduardo Tibirica, MD, PhD

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eduardo Tibiriçá

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

EDUARDO TIBIRICA

Role: CONTACT

+55-21-99914-6075

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eduardo Tibiriçá, MD, PhD

Role: primary

21999146075

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39289473 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAAE 53946021.8.0000.5272

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Angiotensin-(1-7) Cardiovascular Effects in Aging
NCT05301192 RECRUITING EARLY_PHASE1