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Clinical Trials/NCT05797584
NCT05797584RecruitingNot Applicable

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)

Istituto Auxologico Italiano1 site in 1 country60 target enrollmentStarted: March 20, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Right ventricle (RV) volume - Passive leg raining

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

EchocardiocolorDoppler

Other

EchocardiocolorDoppler examination

Intervention: Passive leg raising (Other)

EchocardiocolorDoppler

Other

EchocardiocolorDoppler examination

Intervention: Dobutamine (Drug)

Outcomes

Primary Outcomes

Right ventricle (RV) volume - Passive leg raining

Time Frame: Baseline and at 1 minute after passive leg raising for acute volume load

Change in RV volume

Right ventricle (RV) volume - Dobutamine

Time Frame: Baseline and at 5 minutes after Dobutamine infusion

Change in RV volume

Ejection fraction - Dobutamine

Time Frame: Baseline and at 5 minutes after Dobutamine infusion

Change in ejection fraction

Ejection fraction - Passive leg raining

Time Frame: Baseline and at 1 minute after passive leg raising for acute volume load

Change in ejection fraction

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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