NCT05797584

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

6 years

First QC Date

March 18, 2023

Last Update Submit

March 30, 2023

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

  • Right ventricle (RV) volume - Dobutamine

    Change in RV volume

    Baseline and at 5 minutes after Dobutamine infusion

  • Ejection fraction - Dobutamine

    Change in ejection fraction

    Baseline and at 5 minutes after Dobutamine infusion

  • Right ventricle (RV) volume - Passive leg raining

    Change in RV volume

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

  • Ejection fraction - Passive leg raining

    Change in ejection fraction

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

Study Arms (1)

EchocardiocolorDoppler

OTHER

EchocardiocolorDoppler examination

Drug: DobutamineOther: Passive leg raising

Interventions

DobutamineDRUG

Dobutamine 5.0 - 10.0 mcg/Kg/min ev

EchocardiocolorDoppler
Passive leg raisingOTHER

Passive leg raising for acute volume load

EchocardiocolorDoppler

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Luca IRCCS Istituto Auxologico Italiano

Milan, MI, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CatecholaminesAminesOrganic ChemicalsPhenethylaminesEthylaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Sergio Caravita, MD, PhD

CONTACT

+390261911s.caravita@auxologico.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2023

First Posted

April 4, 2023

Study Start

March 20, 2019

Primary Completion

March 20, 2025

Study Completion

March 20, 2026

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

IT(1)