The Usefulness of Non-invasive Assessment of Haemodynamic Profile in the Diagnosis and Treatment of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 24-h mean Systolic Blood Pressure (in ABPM)
研究概览
简要总结
Arterial hypertension (AH) is an important clinical social and economic problem. In the pathogenesis of AH increased BP is a result of complex mechanisms i. e. fluid retention, increased vascular resistance and hyperkinetic heart function. Impedance cardiography (ICG) is a simple and safe, non-invasive method of hemodynamic monitoring which allows simultaneous assessment of i. e. BP, cardiac index, heart rate, the fluid content in the chest and systemic vascular resistance.
The detailed effect of treatment based on ICG has not been evaluated so far in the long-term observation and for other clinically relevant parameters, such as central blood pressure, left ventricular hypertrophy, metabolic disturbances, parameters of antioxidative-oxidative balance and endothelial function. Therefore, the following main objectives of the study were defined:
- Evaluation of usefulness of impedance cardiography in optimizing treatment of patients with hypertension in the area of reduction and control of blood pressure, hemodynamic parameters, biochemical markers and quality of life.
- Evaluation of complex pathophysiological mechanisms associated with hypertension including hemodynamic, anthropometric, psychological and biochemical parameters as well as the effect of antihypertensive treatment on these phenomena.
The study will be randomized (1:1), prospective and controlled in parallel with conventional treatment. The subjects will be divided into groups according to the pre-established random order:
- empiric group (GE), in which treatment choice will be based on clinical data and current guidelines
- hemodynamic group (HD), in which treatment choice will be based on clinical data and current guidelines considering hemodynamic parameters established with ICG method.
All patients will undergo a detailed examination three times: before treatment, then after 3 and 12 months of treatment.
The authors expect that the study will consolidate the importance of ICG in the diagnosis of patients with AH. Simultaneous multiparametric evaluation of the subjects guarantees a unique and innovative results which can enhance our knowledge in pathophysiology of AH and reversibility of adverse mechanisms associated with this disease.
详细描述
THE IMPORTANCE OF THE PROJECT. Arterial Hypertension (AH) is an important clinical social and economic problem and a major risk factor of coronary artery disease, heart failure, kidney failure and stroke. The risk of organ damage can be significantly reduced just by achieving proper control of blood pressure (BP). In the pathogenesis of AH increased BP is a result of complex mechanisms i. e. fluid retention, increased vascular resistance and hyperkinetic heart function. Impedance cardiography (ICG) is a simple and safe, non-invasive method of hemodynamic monitoring which allows simultaneous assessment of i. e. BP, cardiac index, heart rate, the fluid content in the chest and systemic vascular resistance. The studies conducted so far (including the applicant's own studies) have demonstrated that ICG provided a better selection of drugs and their doses in the short-term observation.
The detailed effect of such treatment strategy has not been evaluated so far in the long-term observation and for other clinically relevant parameters, such as central blood pressure, left ventricular hypertrophy, pulse wave velocity, metabolic disturbances, parameters of antioxidative-oxidative balance and endothelial function. Undoubtedly, such an evaluation may be of high importance in evaluating complex pathophysiological mechanisms associated with cardiovascular hemodynamics. It is expected that the results of this study performed in a group representing a large population of hypertensive patients will allow highly objective, multiparametric evaluation of the usefulness of ICG in hypotensive therapy. The conclusions may be clinically, socially and economically important, especially in terms of effectiveness and continuity of treatment in patients with AH and primary prevention of cardiovascular events and organ damage.
THE CONCEPT AND STUDY DESIGN.
The main aims:
- Evaluation of usefulness of impedance cardiography in optimizing treatment of patients with hypertension in the area of reduction and control of blood pressure, hemodynamic parameters, biochemical markers and quality of life.
- Evaluation of complex pathophysiological mechanisms associated with hypertension including hemodynamic, anthropometric, psychological and biochemical parameters as well as the effect of antihypertensive treatment on these phenomena.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •untreated AH (elevated BP values ≥ 3 months) and insufficiently controlled AH by one or two antihypertensive drugs.
排除标准
- •confirmed secondary AH,
- •improperly controlled AH with three or more medicines
- •chronic renal failure in the third and higher stages of the disease,
- •other severe concomitant diseases: systolic heart failure, cardiomyopathy, significant cardiac arrhythmia, significant valvular disease, chronic obstructive pulmonary disease (stage C/D), diabetes, previously undetected, polyneuropathy, peripheral vascular disease,
- •body mass index (BMI) > 40 kg/m2,
- •mental illness, preventing cooperation with the physician,
- •heart rhythm other than sinus (including, i.e. constant heart stimulation),
研究组 & 干预措施
Empiric Group
The treatment choice based on current guidelines (blinded to ICG).
Monotherapy or combined therapy in case of office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: lisinopril (Drug)
Hemodynamic group
The treatment choice based on hemodynamic parameters established with ICG method.
Monotherapy or combined therapy in case of 1/ complex hemodynamic disturbances and/or 2/ office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: lisinopril (Drug)
Hemodynamic group
The treatment choice based on hemodynamic parameters established with ICG method.
Monotherapy or combined therapy in case of 1/ complex hemodynamic disturbances and/or 2/ office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Telmisartan (Drug)
Hemodynamic group
The treatment choice based on hemodynamic parameters established with ICG method.
Monotherapy or combined therapy in case of 1/ complex hemodynamic disturbances and/or 2/ office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Nebivolol (Drug)
Hemodynamic group
The treatment choice based on hemodynamic parameters established with ICG method.
Monotherapy or combined therapy in case of 1/ complex hemodynamic disturbances and/or 2/ office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Indapamide/hydrochlorothiazide (Drug)
Hemodynamic group
The treatment choice based on hemodynamic parameters established with ICG method.
Monotherapy or combined therapy in case of 1/ complex hemodynamic disturbances and/or 2/ office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Amlodipine (Drug)
Empiric Group
The treatment choice based on current guidelines (blinded to ICG).
Monotherapy or combined therapy in case of office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Telmisartan (Drug)
Empiric Group
The treatment choice based on current guidelines (blinded to ICG).
Monotherapy or combined therapy in case of office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Nebivolol (Drug)
Empiric Group
The treatment choice based on current guidelines (blinded to ICG).
Monotherapy or combined therapy in case of office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Indapamide/hydrochlorothiazide (Drug)
Empiric Group
The treatment choice based on current guidelines (blinded to ICG).
Monotherapy or combined therapy in case of office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg
干预措施: Amlodipine (Drug)
结局指标
主要结局
24-h mean Systolic Blood Pressure (in ABPM)
时间窗: after 12 months from recruitment
24-h mean Diastolic Blood Pressure (in ABPM)
时间窗: after 12 months from recruitment
daytime mean Systolic Blood Pressure (in ABPM)
时间窗: after 12 months from recruitment
daytime mean Diastolic Blood Pressure (in ABPM)
时间窗: after 12 months from recruitment
night-time mean Systolic Blood Pressure (in ABPM)
时间窗: after 12 months from recruitment
night-time mean Diastolic Blood Pressure (in ABPM)
时间窗: after 12 months from recruitment
Systolic Blood Pressure (in OBPM)
时间窗: after 12 months from recruitment
Diastolic Blood Pressure (in OBPM)
时间窗: after 12 months from recruitment
次要结局
- change from baseline in Systolic Blood Pressure (in OBPM) at 3 months(after 12 months from recruitment)
- change from baseline in Diastolic Blood Pressure (in OBPM) at 3 months(after 12 months from recruitment)
- change from baseline in 24-h Systolic Blood Pressure (in ABPM) at 3 months(after 12 months from recruitment)
- change from baseline in 24-h Diastolic Blood Pressure (in ABPM) at 3 months(after 12 months from recruitment)
- change from baseline in daytime Systolic Blood Pressure (in ABPM) at 3 months(after 12 months from recruitment)
- change from baseline in daytime Diastolic Blood Pressure (in ABPM) at 3 months(after 12 months from recruitment)
- change from baseline in night-time Systolic Blood Pressure (in ABPM) at 3 months(after 12 months from recruitment)
- change from baseline in night-time Diastolic Blood Pressure (in ABPM) at 3 months(after 12 months from recruitment)
研究者
Paweł Krzesiński
MD, PhD, Assistant Lecturer in the Department of Cardiology and Internal Diseases
Military Institute od Medicine National Research Institute