NCT06200636已完成不适用
Edge AI-deployed DIGItal Twins for PREDICTing Disease Progression and Need for Early Intervention in Infectious and Cardiovascular Diseases Beyond COVID-19 - Investigation of Biomarkers in Dermal Interstitial Fluid
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients
研究概览
简要总结
The study will investigate, if inflammatory and cardio-circulatory biochemical biomarkers are detectable in dermal interstitial fluid (dISF) of heart failure patients, and if there are detectable kinetics of these biomarkers during a cardiopulmonary exercise test. For dISF extraction the PELSA System - an investigational device - will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject suffers from heart failure (according to ESC 2021 Heart Failure Guidelines).
- •Age of subject is ≥18 years.
- •Subject is female or male.
- •Signed written informed consent.
- •For female subjects:
- •Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
- •If being of childbearing potential:
- •Negative highly sensitive urine or serum pregnancy test before inclusion, and
- •Practicing a highly effective birth control method (failure rate of less than 1%):
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
- •progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
- •intrauterine device (IUD), or
- •intrauterine hormone-releasing system (IUS), or
- •bilateral tubal occlusion, or
- •vasectomised partner, or
- •heterosexual abstinence.
- •Subject is capable to perform cardiopulmonary exercise testing.
排除标准
- •Subject is breastfeeding.
- •Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study.
- •Subject is treated with immunosuppressive drugs at enrolment.
- •Subject requires renal replacement therapy.
- •Subject has a known colonisation or infection with multi-drug-resistant pathogens.
- •Subject has an open wound in or near the sampling area.
- •Subject has any type of tattoo or piercing anywhere in or near the sampling area.
- •Subject shows an inability to comply with all the study procedures and follow-up visits.
- •Subject is unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.
- •Subject is legally detained in an official institution.
- •Subject is dependent on the sponsor, the investigator or the study sites.
- •Subject participates in a study according to AMG/CTR that investigates immunosuppressive or anticoagulant drugs at the time of this study.
研究组 & 干预措施
Interventional group
Experimental
This arm inclcudes all study participants.
干预措施: Use of the PELSA System for dISF extraction (Device)
结局指标
主要结局
Detection of inflammatory and cardio-circulatory biochemical biomarkers in dermal interstitial fluid of heart failure patients
时间窗: Before, immediate after and 30 min after a cardiopulmonary exercise test.
Level above the limit of quantification of the investigated biomarkers in dermal interstitial fluid.
次要结局
- Relationship between the levels of biochemical inflammatory and cardio-circulatory biomarkers in dermal interstitial fluid and their blood levels in heart failure patients.(Before, immediate after and 30 min after a cardiopulmonary exercise test.)
- Safety of the PELSA system in relation to its intended use.(Before, immediate after and 30 min after a cardiopulmonary exercise test.)
- Relationship between kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing.(Before, immediate after and 30 min after a cardiopulmonary exercise test.)
- Performance of the PELSA system in relation to its intended use.(Before, immediate after and 30 min after a cardiopulmonary exercise test.)
- Kinetics of inflammatory and cardio-circulatory biochemical biomarker levels in dermal interstitial fluid and in blood of heart failure patients during exercise testing.(Before, immediate after and 30 min after a cardiopulmonary exercise test.)
研究者
Laurenz Kopp Fernandes
Senior physician, Transplant Outpatient Unit
Charite University, Berlin, Germany
研究点 (1)
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