The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: skin microvascular reactivity.
- Who it may be relevant to
- Registry conditions: Heart Transplantation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test skin microvascular reactivity
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.
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- capability to understand the objectives of the research and to fulfill the Term of Consent
Exclusion criteria
- Pregnancy, acute infection diagnosis, use of circulatory assistance devices
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Eduardo Tibiriçá — Rio de Janeiro
Identifiers
NCT: NCT05729009 · 45581521.0.0000.5272