NCT05729009

The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 31 (estimated)
• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-02-15
• Last updated: 2026-04-13

Locations

1 site across 1 country: Brazil