Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2019-03-20
2026-03-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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EchocardiocolorDoppler
EchocardiocolorDoppler examination
Dobutamine
Dobutamine 5.0 - 10.0 mcg/Kg/min ev
Passive leg raising
Passive leg raising for acute volume load
Interventions
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Dobutamine
Dobutamine 5.0 - 10.0 mcg/Kg/min ev
Passive leg raising
Passive leg raising for acute volume load
Eligibility Criteria
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Inclusion Criteria
* echocardiographic acoustic window adequate for evaluation of outcome parameters
* presence of tricuspid insufficiency which allows assessment of pulmonary artery systolic pressure
Exclusion Criteria
* moderate o severe aortic or mitralic valve disease
* inadequate acoustic window
* significant anemia (hemoglobin \<10 g/dl)
* recent heart surgery (\< 3 months).
ALL
Yes
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Locations
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Ospedale San Luca IRCCS Istituto Auxologico Italiano
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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09C923
Identifier Type: -
Identifier Source: org_study_id
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