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The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05729009
Enrollment
31
Registered
2023-02-15
Start date
2022-10-01
Completion date
2026-12-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Brief 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.

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_TESTskin 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.

Sponsors

National Institute of Cardiology, Laranjeiras, Brazil
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivityMicrovascular 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.

Countries

Brazil

Contacts

CONTACTEduardo Tibirica Tibirica, MD, PhD
etibi@uol.com.br+55-21-99914-6075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026