Clinical trial NCT05797584: Right Ventricular Contractile Reserve in HF
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Right ventricle (RV) volume - Dobutamine
timeFrame: Baseline and at 5 minutes after Dobutamine infusion
measure: Ejection fraction - Dobutamine
timeFrame: Baseline and at 5 minutes after Dobutamine infusion
measure: Right ventricle (RV) volume - Passive leg raining
timeFrame: Baseline and at 1 minute after passive leg raising for acute volume load
measure: Ejection fraction - Passive leg raining
timeFrame: Baseline and at 1 minute after passive leg raising for acute volume load
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano
state: MI
Study officials:
References: