Cardiovascular Response to Exercise in Hypertension (ASSECURE)
Multivariate ASSEssment of CardiovascUlar Response to the Controlled Exercise in Patients With Hypertension - Prospective and Observational Study (ASSECURE Study)
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.
研究概览
地位
条件
详细说明
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:
- The identification of the new markers of cardiovascular risk in patients with arterial hypertension..
- The identification of the new markers of progression from normal left ventricular diastolic function to left ventricular diastolic dysfunction.
- The identification of the new noninvasive markers of progression to symptomatic heart failure.
- The evaluation of the feasibility and usefulness of new methods of noninvasive hemodynamic monitoring (impedance cardiography and applanation tonometry) in the assessment of the cardiovascular hemodynamic response to exercise.
- Multivariate assessment of cardiovascular response to the controlled exercise, taking into account left ventricular diastolic function and symptoms of heart failure.
- The relation between laboratory markers of left ventricular remodeling with resting and exercise (noninvasive) hemodynamics.
The study will be performed in a prospective and observational design. No less than 120 hypertensive subjects will be enrolled.
After recruitment the following assessment will be performed:
- anamnesis and physical examination with anthropometrics (including body composition analysis with use of bioimpedance method);
- electrocardiogram;
- echocardiography (resting), including assessment of left ventricular systolic (2-D left ventricular ejection fraction, longitudinal strain) and diastolic function (including tissue Doppler imaging);
- impedance cardiography (resting);
- Applanation tonometry (resting);
- 24-h Holter-ekg (including heart rate variability analysis);
- 24-h ambulatory blood pressure monitoring;
- flow-mediated dilation of brachial artery (FMD);
- 6-minute walking test (6-MWT);
- Cardiopulmonary exercise test (CPET), supported by hemodynamic monitoring with impedance cardiography and applanation tonometry;
- Quality of life assessment (SF 36 questionnaire);
- Laboratory tests (including creatinine, urea, uric acid, lipids, glucose, microalbuminuria, N-terminal of the prohormone brain natriuretic peptide, galectin-3, copeptin, soluble ST2, Growth differentiation factor 15 (GDF-15), human tissue inhibitor of metalloproteinases 1 (TIMP-1), metalloproteinase 2 (MMP-2), metalloproteinase 9 (MMP-9), syndecan-1).
After 12 months (first control visit) and 24 months (second control visit) the echocardiography and clinical assessment (HF symptoms) will be performed to identify: 1/ patients with new onset LVDdf (among group N); 2/ patients with new onset HF (among group D)
Morover, the follow-up of min 48 months concerning cardiovascular events will be performed (as defined below)
研究类型
注册 (实际的)
联系人和位置
学习地点
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Mazovia
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Warsaw、Mazovia、波兰、04-141
- Military Institute of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- patients of either sex
- age 40-75 years
- arterial hypertension diagnosed ≥3 months before recruitment.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Group N
The subjects with no symptoms of HF and normal left ventricular diastolic function (no less than 40 subjects)
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Group D
The subjects with no symptoms of HF and left ventricular diastolic dysfunction (no less than 40 subjects)
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Group D_HF
The subjects with symptoms of HF and left ventricular diastolic dysfunction (no less than 40 subjects)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
complex end-point (death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure)
大体时间:48 months
|
Any of the following cardiovascular events: death from cardiovascular causes and/or myocardial infarction and/or stroke and/or decompensated heart failure
|
48 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
death from any cause
大体时间:48 months
|
48 months
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death from cardiovascular causes
大体时间:48 months
|
48 months
|
myocardial infarction
大体时间:48 months
|
48 months
|
decompensated heart failure
大体时间:48 months
|
48 months
|
stroke
大体时间:48 months
|
48 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
new-onset of heart failure after 12 months (in groups N i D)
大体时间:12 months
|
based on questionnaire
|
12 months
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new-onset of heart failure after 24 months (in groups N i D)
大体时间:24 months
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based on questionnaire
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24 months
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new-onset of left ventricular diastolic dysfunction in echocardiography after 12 months (in group N)
大体时间:12 months
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12 months
|
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new-onset of left ventricular diastolic dysfunction in echocardiography after 24 months (in group N)
大体时间:24 months
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24 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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