Heart TransplantationNCT05729009
The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients
An observational study of Heart Transplantation, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- skin microvascular reactivity
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: adult individuals from the cohort of heart failure patients under evaluation for heart transplantation, at the National Institute of Cardiology, Rio de Janeiro, Brazil
Who may be able to join
- capability to understand the objectives of the research and to fulfill the Term of Consent
Who cannot join
- Pregnancy, acute infection diagnosis, use of circulatory assistance devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Eduardo Tibiriçá
Rio de Janeiro, 22240006
Eduardo Tibiriçá, MD, PhD, 21999146075, etibi@oul.com.br
About this study
The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.
Read the detailed description
Introduction: Systemic microvascular reactivity (MR) is an essential component of cardiovascular physiology, being studied through non-invasive techniques in readily accessible body regions, such as the skin surface. Heart transplant (HT) is a treatment considered to selected patients, with advanced heart failure. The main cause of long-term mortality after HT is graft vascular disease (GVD), a condition which starts with endothelial dysfunction. To know the evolution of systemic MR in patients subjected to HT can help to find prognostic factors. Objective: The present study aims to perform the prospective evaluation of systemic MR in adult patients, before and two years after HT, at a quaternary hospital, correlating the findings with clinical variables. Methods: Systemic MR will be evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis, followed by postocclusive reactive hyperemia (PORH), before and after HT. Measurements will be correlated to patient clinical profile, hemodynamic and echocardiographic data. Expected results: The evolution of systemic MR may aid in the comprehension of cardiovascular physiology in HT patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.
- Conditions
- Heart Transplantation
- Being tested
- skin microvascular reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin microvascular reactivityDiagnostic 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 |
|---|---|---|
| heart transplantation | Not described Receives: Diagnostic Test: skin microvascular reactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agents. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Measured: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies 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
- 31 participants (estimated)
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
- NCT05729009
- Sponsor's protocol ID
- 45581521.0.0000.5272
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients
- ClinicalTrials.gov ID
- NCT05729009
- Acronym / sponsor ID
- 45581521.0.0000.5272
- Conditions
- Heart Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 2023 (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.
The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.
Detailed description
Introduction: Systemic microvascular reactivity (MR) is an essential component of cardiovascular physiology, being studied through non-invasive techniques in readily accessible body regions, such as the skin surface. Heart transplant (HT) is a treatment considered to selected patients, with advanced heart failure. The main cause of long-term mortality after HT is graft vascular disease (GVD), a condition which starts with endothelial dysfunction. To know the evolution of systemic MR in patients subjected to HT can help to find prognostic factors. Objective: The present study aims to perform the prospective evaluation of systemic MR in adult patients, before and two years after HT, at a quaternary hospital, correlating the findings with clinical variables. Methods: Systemic MR will be evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis, followed by postocclusive reactive hyperemia (PORH), before and after HT. Measurements will be correlated to patient clinical profile, hemodynamic and echocardiographic data. Expected results: The evolution of systemic MR may aid in the comprehension of cardiovascular physiology in HT patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heart transplantation | – | Diagnostic Test: skin microvascular reactivity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult individuals from the cohort of heart failure patients under evaluation for heart transplantation, at the National Institute of Cardiology, Rio de Janeiro, Brazil
Key inclusion criteria (1 listed)
- capability to understand the objectives of the research and to fulfill the Term of Consent
Key exclusion criteria (1 listed)
- Pregnancy, acute infection diagnosis, use of circulatory assistance devices
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 |
|---|---|---|
| skin microvascular reactivityLaser-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 | heart transplantation |
Primary outcome
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agents. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
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 Heart Transplantation, 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 1 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Tibirica Tibirica, MD, PhD (+55-21-99914-6075, etibi@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity (time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.). 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 13 Apr 2026.