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NCT Number: NCT05729009

The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eduardo Tibiriçá

Rio de Janeiro, 22240006, Brazil

Location status: Recruiting

Location contact

Eduardo Tibiriçá, MD, PhD

CONTACT

[email protected]

21999146075

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skin microvascular reactivity

Diagnostic 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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Tibirica Tibirica, MD, PhD

CONTACT

[email protected]

+55-21-99914-6075

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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