NCT02922478已完成不适用
Role of Comorbidities in Chronic Heart Failure (RoC-HF) Study
Medical University of Graz1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2016年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Prevalence of vertebral fractures in chronic heart failure
研究概览
简要总结
This study aims to create a database of patients with stable and chronic heart failure with comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine samples will be stored to facilitate future biomarker analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •NYHA (New York Heart Association) class II-IV symptoms
- •Left ventricular ejection fraction < 50% at Visit
- •Treatment according to current Heart Failure Guidelines of the European Society of Cardiology
- •Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures
- •Previous diagnosis of heart failure with reduced ejection fraction defined as symptomatic left ventricular ejection < 40% requiring optimization of heart failure therapy
排除标准
- •Unplanned hospitalization within 1 month prior to the Baseline Visit.
- •Discontinuation or initiation of a pharmacologic or device treatment for HFrEF within 1 month prior to the baseline visit.
- •Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
- •Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
- •Any acute illness
- •Disease reducing life expectancy to < 1 year, except HFrEF
- •Recipient of any organ transplant
- •Primary significant valve disease (at least moderate to severe valve disease)
结局指标
主要结局
Prevalence of vertebral fractures in chronic heart failure
时间窗: 1 day
Prevalence of osteoporosis in chronic heart failure
时间窗: 1 day
次要结局
- Peripheral and central pulse wave velocity(24 hours)
- 24-hours systolic and diastolic blood pressure(24 hours)
研究者
Dirk von Lewinski
Clinical Professor
Medical University of Graz
研究点 (1)
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