Right Ventricular Contractile Reserve in HF (RISE-HF)

March 30, 2023 updated by: Istituto Auxologico Italiano

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20149
        • Recruiting
        • Ospedale San Luca IRCCS Istituto Auxologico Italiano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EchocardiocolorDoppler
EchocardiocolorDoppler examination
Drug: Dobutamine
Dobutamine 5.0 - 10.0 mcg/Kg/min ev
Other: Passive leg raising
Passive leg raising for acute volume load

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Anticipated)

March 20, 2025

Study Completion (Anticipated)

March 20, 2026

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C923

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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