Right Ventricular Contractile Reserve in HF

Heart Failure Clinical Trial

— RISE-HF  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797584
• Other study ID #: 09C923
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: March 20, 2026

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Sergio Caravita, MD, PhD
• Phone: +390261911
• Email: s.caravita[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 20, 2026
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Dobutamine
Dobutamine 5.0 - 10.0 mcg/Kg/min ev

Other:
• Passive leg raising
Passive leg raising for acute volume load

Locations

Country	Name	City	State
Italy	Ospedale San Luca IRCCS Istituto Auxologico Italiano	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

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