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临床试验/NCT05729009
NCT05729009
招募中
不适用

The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

National Institute of Cardiology, Laranjeiras, Brazil2 个研究点 分布在 1 个国家目标入组 31 人2022年10月1日

概览

阶段
不适用
干预措施
skin microvascular reactivity
疾病 / 适应症
Heart Transplantation
发起方
National Institute of Cardiology, Laranjeiras, Brazil
入组人数
31
试验地点
2
主要终点
Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity
状态
招募中
最后更新
19天前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2022年10月1日
结束日期
2026年12月1日
最后更新
19天前
研究类型
Observational
性别
All

研究者

发起方
National Institute of Cardiology, Laranjeiras, Brazil
责任方
Principal Investigator
主要研究者

Eduardo Tibirica, MD, PhD

Principal Investigator

National Institute of Cardiology, Laranjeiras, Brazil

入排标准

入选标准

  • capability to understand the objectives of the research and to fulfill the Term of Consent

排除标准

  • Pregnancy, acute infection diagnosis, use of circulatory assistance devices

研究组 & 干预措施

heart transplantation

干预措施: skin microvascular reactivity

结局指标

主要结局

Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity

时间窗: 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.

研究点 (2)

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