Right Ventricular Contractile Reserve in HF

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Drug: Dobutamine; Other: Passive leg raising

• Registration Number: NCT05797584
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Primary Completion: 2025-03-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EchocardiocolorDoppler	Passive leg raising	EchocardiocolorDoppler examination
EchocardiocolorDoppler	Dobutamine	EchocardiocolorDoppler examination

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale San Luca IRCCS Istituto Auxologico Italiano; 🇮🇹 Milan, MI, Italy