Right Ventricular Contractile Reserve in HF

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Dobutamine
* Other: Passive leg raising


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EchocardiocolorDoppler<br>EchocardiocolorDoppler examination | Drug: Dobutamine<br>* Dobutamine 5.0 - 10.0 mcg/Kg/min ev<br>Other: Passive leg raising<br>* Passive leg raising for acute volume load<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricle (RV) volume - Dobutamine | Change in RV volume | Baseline and at 5 minutes after Dobutamine infusion | 
| Ejection fraction - Dobutamine | Change in ejection fraction | Baseline and at 5 minutes after Dobutamine infusion | 
| Right ventricle (RV) volume - Passive leg raining | Change in RV volume | Baseline and at 1 minute after passive leg raising for acute volume load | 
| Ejection fraction - Passive leg raining | Change in ejection fraction | Baseline and at 1 minute after passive leg raising for acute volume load |