Morphological and Functional Phenotype of Isolated Microvascular Cardiac Allograft Vasculopathy in Heart Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- mCAV status influences pw-doppler wall motion analysis in echocardiography
研究概览
简要总结
The aim of the mCAV study is a comprehensive characterization of the genetic, morphological and functional phenotype of isolated microvascular graft vasculopathy (mCAV) after orthotopic heart transplantation (OHT).
The utilized methods include dynamic echocardiography, magnetic resonance imaging, invasive microvascular resistance measurements, histology, cellular calcium-signaling and magnetocardiography as well as molecular genetic expression analysis (miRNA based).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to consent
- •Written consent of the participant after clarification and sufficient time to think about participation
- •heart transplant recipient
- •Indication for routine invasive diagnostics or due to symptoms
- •Exercise tolerant in everyday life - cycling, climbing stairs at least 2 floors at a moderate speed without symptoms of exertion or dyspnea
排除标准
- •Addiction or other diseases that do not allow the patient to assess the nature and scope as well as possible consequences of the study
- •Patients or their legal guardians who do not sign the declaration of consent or who cannot fully understand it due to a lack of German language skills
- •Pregnant women, breastfeeding women
- •Severe comorbidities affecting the miRNA profile: diabetes mellitus, malignancy, end-stage renal disease with renal replacement therapy
- •Contraindication to the stress test: signs of cardiac decompensation, angina pectoris, dyspnea, hyperthyroidism, GFR <30 ml/min, peripheral arterial disease, pheochromocytoma, angle-closure glaucoma, prostate adenoma, paroxysmal tachycardia, tachycardia atrial fibrillation
- •Evidence of an acute rejection or local wall motion disturbances in the resting echocardiography
结局指标
主要结局
mCAV status influences pw-doppler wall motion analysis in echocardiography
时间窗: at study inclusion
pw-doppler wall motion analysis is measured with afterload increase
mCAV status influences grade of fibrosis
时间窗: at study inclusion
fibrosis grades are measured by MRI
mCAV status influences cardiac deformity
时间窗: at study inclusion
cardiac deformity analysis are performed by MRI
mCAV status influences extracellular volume
时间窗: at study inclusion
extracellular volume is measured by MRI
mCAV status influences diastolic strain in echocardiography
时间窗: at study inclusion
diastolic strain is measured by speckle tracking analysis with afterload increase
mCAV status influences global longitudinal strain in echocardiography
时间窗: at study inclusion
global longitudinal strain is measured by speckle tracking analysis with afterload increase
mCAV status influences the circulating miRNA profile
时间窗: at study inclusion
circulating miRNA profile is measured by miRNAseq
次要结局
- mCAV status influences the cellular calcium signaling(at study inclusion)
- mCAV status influences subcellular structures(at study inclusion)
- mCAV status influences the intrinsic cardiac magnetic field(at study inclusion)