Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cardiac tissutal mRNAs signatures
研究概览
简要总结
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.
详细描述
The investigators will collect plasma and cardiac tissue specimens from consenting subjects. The investigators will evaluate the expression of mRNAs, miRNAs and lncRNAs in patients affected by both end-stage and not end-stage HF as well as in patients affected by aortic stenosis and undergoing valve replacement and requiring cardiac myectomy. The tissue dysregulated RNAs will be next measured in plasma samples in order to clarify their potential as biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non end-stage heart failure
- •left ventricle restoration surgery (SVR)
- •End Systolic Volume Index (ESVI) >35 ml/m2
- •Ejection Fraction (EF)<40%
- •previous transmural anterior myocardial infarction (MI)
- •age: 40-75
- •End-stage heart failure
- •left ventricle assisted device (LVAD) surgery
- •age: 40-75
- •Ejection Fraction (EF) <25%
- •End Systolic Volume Index (ESVI)≥60 ml/m2
- •Aortic Stenosis
- •aortic valve replacement
- •intracardial pressure difference >40 mmHg
- •septal diameter ≥1.3 cm
排除标准
- •Non end-stage heart failure
- •End Systolic Volume Index (ESVI)<35 ml/m2
- •Ejection Fraction (EF)>40%
- •Time from MI unknown
- •Pregnancy
- •Other genetic diseases
- •Neoplasms
- •Collagenopathies
- •Chemo/radiotherapy
- •Prolonged use of corticosteroids
- •Infections
- •Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
- •End-stage heart failure
- •Time from MI unknown
- •Pregnancy
- •Other genetic diseases
- •Neoplasms
- •Collagenopathies
- •Chemo/radiotherapy
- •Prolonged use of corticosteroids
- •Infections
- •Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
- •Aortic Stenosis
- •coronaropathies
- •Pregnancy
- •Other genetic diseases
- •Neoplasms
- •Collagenopathies
- •Chemo/radiotherapy
- •Prolonged use of corticosteroids
- •Infections
- •Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
结局指标
主要结局
Cardiac tissutal mRNAs signatures
时间窗: from Year 1 to Year 3
The mRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
Cardiac tissutal miRNAs signatures
时间窗: from Year 1 to Year 3
The miRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
Cardiac tissutal lncRNAs signatures
时间窗: from Year 1 to Year 3
The lncRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls
次要结局
- Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas(from Year 3 to Year 5)
- Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas(from Year 3 to Year 5)
- Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas(from Year 3 to Year 5)
研究者
Fabio Martelli
Dr, PhD, Molecular Cardiology Laboratory Director
IRCCS Policlinico S. Donato