Valutazione Ecocardiografica Della Riserva Contrattile Del Ventricolo Destro Dopo Carico Volemico Acuto Mediante Sollevamento Passivo Delle Gambe e Durante Infusione di Dobutamina in Pazienti Affetti da Scompenso Cardiaco a Frazione d'Eiezione Ridotta (HFrEF) e Preservata (HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Right ventricle (RV) volume - Passive leg raining
研究概览
简要总结
Right ventricle dysfunction and pulmonary hypertension are related to a worse prognosis in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) or with normal left ventricular ejection fraction (HFpEF).
There is preliminary evidence however, that the responses of the right ventricle and of the pulmonary hemodynamics to stress tests (especially physical stress) may allow to prognostically stratify these patients, as these responses may bring out latent right ventricle dysfunction or a normal contractile reserve in patients with dysfunction at rest.
In view of the different pathophysiological mechanisms of the left ventricular dysfunction in HFpEF and in HFrEF, also the response and the adaptation of the righty ventricle to stress tests may be different in these two groups of patients.
In this preliminary two groups of 20 patients with HFpEF and HFrEF will be subjected to to simple stress tests: passive leg raising and inotropic stimulus with dobutamine.
This study intends to analyze, through colorDoppler echocardiography, the behaviour of the right ventricle and the pulmonary circulation during passive leg raining and infusion of dobutamine, in a cohort of patients with HFrEF or HFpEF.
The analysis will be focused on the relation between echocardiographic parameters, especially those concerning right ventricular function and pulmonary hemodynamics, thereby comparing the responses observed in HFrEF vs HFpEF.
Furthermore, correlations between the above-mentioned echocardiographic parameters and parameters of daily clinical practice will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •heart failure with reduced (EF ≤40%) or preserved (EF > 50%) ejection fraction
- •echocardiographic acoustic window adequate for evaluation of outcome parameters
- •presence of tricuspid insufficiency which allows assessment of pulmonary artery systolic pressure
排除标准
- •recent myocardial infraction (<3 months) or unstable angina
- •moderate o severe aortic or mitralic valve disease
- •inadequate acoustic window
- •significant anemia (hemoglobin <10 g/dl)
- •recent heart surgery (< 3 months).
研究组 & 干预措施
EchocardiocolorDoppler
EchocardiocolorDoppler examination
干预措施: Dobutamine (Drug)
EchocardiocolorDoppler
EchocardiocolorDoppler examination
干预措施: Passive leg raising (Other)
结局指标
主要结局
Right ventricle (RV) volume - Passive leg raining
时间窗: Baseline and at 1 minute after passive leg raising for acute volume load
Change in RV volume
Right ventricle (RV) volume - Dobutamine
时间窗: Baseline and at 5 minutes after Dobutamine infusion
Change in RV volume
Ejection fraction - Dobutamine
时间窗: Baseline and at 5 minutes after Dobutamine infusion
Change in ejection fraction
Ejection fraction - Passive leg raining
时间窗: Baseline and at 1 minute after passive leg raising for acute volume load
Change in ejection fraction
次要结局
未报告次要终点
