跳至主要内容
临床试验/NCT05797584
NCT05797584招募中不适用

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)

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月20日最近更新:
适应症
干预措施
相关药物

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

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

Other

EchocardiocolorDoppler examination

干预措施: Dobutamine (Drug)

EchocardiocolorDoppler

Other

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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