Right Ventricular Contractile Reserve in HF (RISE-HF)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Passive leg raising; Drug: Dobutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05797584

09C923

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

EchocardiocolorDoppler

Other group

Description:

EchocardiocolorDoppler examination

Treatment:

Drug: Dobutamine

Other: Passive leg raising