Arterial HypertensionNCT03243045
Systemic Microvascular Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
An observational study of Arterial Hypertension and Resistant Arterial Hypertension, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
It has been proposed that the modulation of the activity of the sympathetic nervous system, through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Hypertension, Resistant Arterial Hypertension
- What is being tested?
- Renal sympathetic denervation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 6 Jan 2020
- How long will I take part?
- 1 Year
- 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 80 years
- All sexes
- Adult, Older adult
Study population: patients with a confirmed diagnosis of resistant arterial hypertension who were admitted to the National Institute of Cardiology (NIC) at the Ministry of Health in Rio de Janeiro, Brazil. The NIC is a national reference center for the treatment and research of cardiovascular diseases.
Who may be able to join
- Resistant arterial hypertension under pharmacological treatment
Who cannot join
- secondary arterial hypertension
- renal dysfunction
- severe kidney disease
- congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Systemic Microvascular Density and Endothelial Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
It has been proposed that the modulation of the activity of the sympathetic nervous system, through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation.
The present study aimed to investigate the influence of the renal sympathetic denervation on the skin microvascular function of patients presenting with resistant arterial hypertension.
Read the detailed description
Arterial hypertension is still a serious public health problem with considerable social and economic impact. Arterial hypertension is the result from a complex interaction between environmental and genetic factors that initiate and perpetuate elevated blood pressure. Studies show that about 10% of patients undergoing treatment have resistant hypertension, defined as high blood pressure refractory to at least three antihypertensive drugs. It is known that the sympathetic nervous system plays a fundamental role in the pathophysiology of hypertension, contributing to metabolic and vascular changes. The sympathetic nervous system has also a major role in the pathophysiology of arterial hypertension. Arterial hypertension has also been associated with functional microcirculatory alterations as well as systemic microvascular endothelial dysfunction in hypertensive patients, confirmed by different microcirculatory flowmetry techniques. In this context, it has been proposed that the modulation of the sympathetic nervous system through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation.
The present study aimed to investigate the influence of the renal sympathetic denervation on the skin microvascular function of patients with resistant hypertension.
- Being tested
- Renal sympathetic denervation
- Keywords
- Arterial hypertension, Microcirculation, Sympathetic nervous system
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervationProcedure or surgery
Transcutaneous renal sympathetic denervation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous microvascular reactivity
Evaluation of microvascular reactivity using laser speckle contrast imaging
Measured: Before and one, three, six and twelve months after intervention
Cutaneous microvascular flow
Evaluation of the microvascular flow using laser speckle contrast imaging
Measured: Before and one, three, six and twelve months after intervention
Secondary outcomes (1)
Cutaneous capillary density
Evaluation of cutaneous capillary density and reactivity using video-capillaroscopy
Measured: Before and one, three, six and twelve months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Mar 2017
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Year
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
- Investigators
- EDUARDO V TIBIRICA, MD, PhD, Principal investigator, National Innstitute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243045
- Sponsor's protocol ID
- CAAE-51310815.0.0000.5272
- Status last verified
- Jan 2020
- First submitted
- 3 Aug 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Microvascular Density and Endothelial Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation
- ClinicalTrials.gov ID
- NCT03243045
- Acronym / sponsor ID
- CAAE-51310815.0.0000.5272
- Keywords
- Arterial hypertension, Microcirculation, Sympathetic nervous system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 8 Aug 2017 (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.
It has been proposed that the modulation of the activity of the sympathetic nervous system, through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation.
The present study aimed to investigate the influence of the renal sympathetic denervation on the skin microvascular function of patients presenting with resistant arterial hypertension.
Detailed description
Arterial hypertension is still a serious public health problem with considerable social and economic impact. Arterial hypertension is the result from a complex interaction between environmental and genetic factors that initiate and perpetuate elevated blood pressure. Studies show that about 10% of patients undergoing treatment have resistant hypertension, defined as high blood pressure refractory to at least three antihypertensive drugs. It is known that the sympathetic nervous system plays a fundamental role in the pathophysiology of hypertension, contributing to metabolic and vascular changes. The sympathetic nervous system has also a major role in the pathophysiology of arterial hypertension. Arterial hypertension has also been associated with functional microcirculatory alterations as well as systemic microvascular endothelial dysfunction in hypertensive patients, confirmed by different microcirculatory flowmetry techniques. In this context, it has been proposed that the modulation of the sympathetic nervous system through renal sympathetic denervation, besides reducing blood pressure, would promote an improvement in vascular reactivity and consequent improvement of macro and microcirculation.
The present study aimed to investigate the influence of the renal sympathetic denervation on the skin microvascular function of patients with resistant hypertension.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with a confirmed diagnosis of resistant arterial hypertension who were admitted to the National Institute of Cardiology (NIC) at the Ministry of Health in Rio de Janeiro, Brazil. The NIC is a national reference center for the treatment and research of cardiovascular diseases.
Key inclusion criteria (1 listed)
- Resistant arterial hypertension under pharmacological treatment
Key exclusion criteria (4 listed)
- secondary arterial hypertension
- renal dysfunction
- severe kidney disease
- congestive heart failure
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 |
|---|---|---|
| Renal sympathetic denervationTranscutaneous renal sympathetic denervation | Procedure or surgery | – |
Primary outcome
Cutaneous microvascular reactivity
Time frame: Before and one, three, six and twelve months after intervention
Evaluation of microvascular reactivity using laser speckle contrast imaging
Cutaneous microvascular flow
Time frame: Before and one, three, six and twelve months after intervention
Evaluation of the microvascular flow using laser speckle contrast imaging
1 secondary outcome
Cutaneous capillary density
Time frame: Before and one, three, six and twelve months after intervention
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 7 Jan 2020.
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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.
EDUARDO V TIBIRICA, MD, PhD principal investigator
National Innstitute of Cardiology
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 Arterial 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 4 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 7 Jan 2020. 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?
Cutaneous microvascular reactivity (time frame: Before and one, three, six and twelve months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020.