Right Ventricular Contractile Reserve in HF (RISE-HF)

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: Heart Failure
• Intervention / Treatment: Drug: Dobutamine; Other: Passive leg raising

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Caravita, MD, PhD; Phone Number: 2930 +390261911; Email: s.caravita@auxologico.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20149
      • Recruiting
      • Ospedale San Luca IRCCS Istituto Auxologico Italiano
      • Contact: Sergio Caravita, MD, PhD; Phone Number: 2930 +390261911; Email: s.caravita@auxologico.it

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• 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