Arterial HypertensionNCT05464849
Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension
An observational study of Arterial Hypertension and Resistant Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arterial Hypertension, Resistant Hypertension, Microvascular Rarefaction
- What is being tested?
- Evaluation of systemic skin microvascular endothelial function
- How many people
- 111 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Resistant hypertension
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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
- Arterial Hypertension, Resistant Hypertension, Microvascular Rarefaction, Endothelial Dysfunction
- Being tested
- Evaluation of systemic skin microvascular endothelial function
- Medical subject headings
- Hypertension, Microvascular Rarefaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of systemic skin microvascular endothelial functionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Resistant hypertension | Patients presenting with resistant hypertension Receives: Diagnostic Test: Evaluation of systemic skin microvascular endothelial function | |
| non-resistant hypertension | Patients presenting with non-resistant hypertension Receives: Diagnostic Test: Evaluation of systemic skin microvascular endothelial function | |
| normotensive subjects | control group including normotensive volunteers Receives: Diagnostic Test: Evaluation of systemic skin microvascular endothelial function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic microvascular reactivity
evaluation of endothelium-dependent and -independent microvascular function
Measured: two years - during one visit to the microcirculation laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start20 Dec 2021
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464849
- Sponsor's protocol ID
- CAAE 53946021.8.0000.5272
- Status last verified
- Apr 2026
- First submitted
- 12 Jul 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39289473
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Microvascular Reactivity in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT05464849
- Acronym / sponsor ID
- CAAE 53946021.8.0000.5272
- Conditions
- Arterial Hypertension, Resistant Hypertension, Microvascular Rarefaction, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistant hypertension | – | Diagnostic Test: Evaluation of systemic skin microvascular endothelial functionPatients presenting with resistant hypertension |
| non-resistant hypertension | – | Diagnostic Test: Evaluation of systemic skin microvascular endothelial functionPatients presenting with non-resistant hypertension |
| normotensive subjects | – | Diagnostic Test: Evaluation of systemic skin microvascular endothelial functioncontrol group including normotensive volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Resistant hypertension
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of systemic skin microvascular endothelial functionLaser-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. | Diagnostic test | Resistant hypertension, non-resistant hypertension, normotensive subjects |
Primary outcome
Systemic microvascular reactivity
Time frame: two years - during one visit to the microcirculation laboratory
evaluation of endothelium-dependent and -independent microvascular function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 39289473Crahim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and Resistant Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic microvascular reactivity (time frame: two years - during one visit to the microcirculation laboratory). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.