A Comparison of Arterial Stiffness in Patients With Stable Heart Failure and Stable Chronic Kidney Disease Against Decompensated Heart Failure and Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Pulse Wave Velocity (m/s)
研究概览
简要总结
This observational study is assessing the effects that arterial stiffness may have on patients with heart failure (HF) and chronic kidney disease (CKD). Arterial stiffness will be measured by assessing pulse wave velocity (PWV). Carotid- Femoral PWV is the gold standard in measuring arterial stiffness non- invasively. Many studies have shown increasing PWV is a predictor of cardiovascular events, but the significance of increasing PWV as a surrogate marker for the potential worsening (decompensation) of HF or CKD has not been explored.
This study aims to investigate patients with HF and CKD by assessing PWV while in a decompensated state and again when in a stable condition after 4 weeks of discharge to investigate a link between decompensation and rise of arterial stiffness.
The research team aim to recruit 120 patients in this study with 40 patients in each of the 3 groups- heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and acute kidney injury (AKI). All AKI patients would have had known CKD (stages 3a, 3b or 4).
The study participants will be initially recruited in hospital while admitted in an acute state and tests including bloods, ECG, echocardiography and PWV will be performed. The tests (excluding echocardiography) will be repeated 4 weeks after discharge. There is no intervention in this study.
The study seeks to improve the understanding of the role of the vasculature in the development of acute HF in the two common types- HFrEF and HFpEF. As CKD is a common comorbidity in heart failure patients we felt that a study of the behaviour of arterial stiffness in this cohort will add to this understanding. If arterial stiffness is found to be an important component of the HF syndrome therapeutic interest could be focused at managing arterial stiffness with novel therapy.
详细描述
Research Objective:
The objective of this study is to identify whether or not patients whom are admitted to hospital with acute decompensated heart failure on a background of stable heart failure or acute kidney injury on a background of stable chronic kidney disease stage 3a,3b or 4 show high pulse wave velocity values when compared to being in a stable condition in the community.
This will help improve the understanding in the pathophysiology of decompensated heart failure and acute kidney injury in CKD.
Scientific Justification:
The role of arterial stiffness in the pathophysiology (in particular, the development) of decompensated heart failure is poorly understood. It is suspected that in some types of heart failure (HFpEF) arterial stiffness may be the driving factor for both acute and chronic types but evidence on this is still incomplete.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female age ≥60 Known or documented diagnosis of Heart Failure ( Heart Failure with reduced ejection fraction HFrEF or Heart Failure with preserved ejection fraction HFpEF) on admission or prior to admission. HFrEF is defined as Left Ventricular ejection fraction (LVEF) of <40%, HFpEF is defined as LVEF >50% as in accordance with the classification by the European Society of Cardiology.
- •Patients on optimal evidence based therapy for heart failure Known or documented diagnosis of Chronic Kidney Disease stage 3a, 3b or 4, for minimum period of ≥6 months
排除标准
- •Severe Peripheral Vascular Disease Patients who have had a myocardial infarction or coronary artery bypass surgery within 6 months Severe Anaemia Hb 70g/dl Dementia or unable to consent lack mental capacity Bedbound/ Immobile patients Severe Liver Failure Severe Chronic Obstructive Pulmonary Disease Patients on LTOT (Long Term Oxygen Therapy) Renal transplant Previous or Current Renal Replacement Therapy (Peritoneal Dialysis or Haemodialysis) Sepsis
结局指标
主要结局
Pulse Wave Velocity (m/s)
时间窗: 12 months
PWV is a measure of arterial stiffness which can be done non invasively at bedside using a device called SphygmoCor CVMS machine (Atcor Medical, Sydney, Australia
次要结局
- Assess the relationship between NYHA heart failure class and PWV(12 months)
- Assess the relationship between CKD stage and PWV(12 months)
- Assess any correlation between non invasive blood pressure & PWV(12 months)