Multivariate ASSEssment of CardiovascUlar Response to the Controlled Exercise in Patients With Hypertension - Prospective and Observational Study (ASSECURE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- complex end-point (death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure)
研究概览
简要总结
Arterial hypertension (AH) is an important clinical social and economic problem, related to the increased cardiovascular risk. AH is associated with cardiovascular hemodynamic alterations, including left ventricular diastolic dysfunction (LVddf). In consequence of increased blood pressure, the effectiveness of LV as a blood pump decreases and the symptoms of heart failure (HF) may occur. Thus, the identification of noninvasive markers related with the progression from the asymptomatic AH to LVddf/HFpEF would be beneficial.
Another issue is that the diagnostic difficulties in patients with LVddf and HFpEF stem from the limited possibility to assess the hemodynamic response to exercise. Thus, there is a need for more detailed methods of cardiovascular monitoring while exercise testing.
We hypothesize that some new noninvasive hemodynamic parameters, characterizing left ventricular (LV) function and arterial stiffness, may help to predict the risk of cardiovascular events and future occurrence of LVddf/HFpEF. Moreover, we assume that cardiopulmonary exercise test (CPET), completed with new methods of noninvasive hemodynamic monitoring (impedance cardiography and applanation tonometry), would provide additional value in the assessment of the cardiovascular hemodynamic response to exercise.
The study is intended to verify these hypothesis.
详细描述
Arterial hypertension (AH) is an important clinical social and economic problem, related to the increased cardiovascular risk.
AH is associated with cardiovascular hemodynamic alterations, including left ventricular diastolic dysfunction (LVddf). In consequence of increased blood pressure, the effectiveness of LV as a blood pump decreases and the symptoms of heart failure (HF), even with preserved ejection fraction (HFpEF), may occur. At the early stage, patients' complaints are not specific and difficult to clinical interpretation. As a consequence, these subjects frequently remain undiagnosed. Thus, the identification of noninvasive markers related with the progression from the asymptomatic AH to LVddf/HFpEF would be beneficial.
Another issue is that the diagnostic difficulties in patients with LVddf and HFpEF stem from the limited possibility to assess the hemodynamic response to exercise. Thus, there is a need for more detailed methods of cardiovascular monitoring while exercise testing.
The investigators hypothesize that some new noninvasive hemodynamic parameters, characterizing left ventricular (LV) function and arterial stiffness, may help to predict the risk of cardiovascular events and future occurrence of LVddf/HFpEF. Moreover, the investigators assume that cardiopulmonary exercise test (CPET), completed with new methods of noninvasive hemodynamic monitoring (impedance cardiography and applanation tonometry), would provide additional value in the assessment of the cardiovascular hemodynamic response to exercise.
Aims:
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either sex
- •age 40-75 years
- •arterial hypertension diagnosed ≥3 months before recruitment.
排除标准
- •office blood pressure > 160/100 mmHg
- •coronary artery disease
- •systolic heart failure (LVEF below 45%) and/or severe heart defect (i.e. valvular disease)
- •severe pulmonary diseases (COPD stage C/D, uncontrolled asthma, pulmonary hypertension, pulmonary embolism)
- •chronic kidney disease (MDRD eGFR<60 ml/min/1.73m2)
- •severe inflammatory disease
- •severe mental and physical disorders
- •polyneuropathy
- •obesity with BMI > 40 kg/m2
- •life expectancy less than 12 months in the opinion of the physician
- •patients' refusal to participate.
结局指标
主要结局
complex end-point (death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure)
时间窗: 48 months
Any of the following cardiovascular events: death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure
次要结局
- myocardial infarction(48 months)
- death from cardiovascular causes(48 months)
- death from any cause(48 months)
- decompensated heart failure(48 months)
- stroke(48 months)
研究者
Paweł Krzesiński
Lecturer
Military Institute od Medicine National Research Institute