Right Ventricular Dysfunction in Chronic Heart Failure

NCT ID: NCT06002321

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-09-01

Brief Summary

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The goal of this multi center observational prospective study is to analyze the concordance between the signs and symptoms of RHF and echocardiographic features of RVD in patient with heart failure. The main questions it aims to answer are:

1. to assess the incidence of RVH and RVD in each HF subtypes.
2. to evaluate prognostic impact ( in terms of cardiovascular mortality and HF hospitalization) of different RVD patterns during a mean followup period of 3 years
3. To investigate the incidence of different RV maladaptation ( isolated RV dilatation, isolated Pulmonary hypertension, combined pattern) in each HF groups and the related outcome.

Participants will follow by direct check up visit and/or virtual visits every 6 months for a mean follow-up period of 3 years.

Detailed Description

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Right ventricular dysfunction (RVD) and pulmonary hypertension (PH) have been recognized as two important prognostic features in patients with left side heart failure (HF). Nevertheless literature does not distinguish between right heart failure (RHF) and RVD, and the two terms are indifferently employed to describe PH and impaired RV performance. This is a multicenter observational prospective study endorsed by the Italian Society of Cardiology that would analyse the concordance between the signs and symptoms of RHF and echocardiographic features of RVD. Therefore the right ventricle (RV) adaptation across different left ventricular ejection fraction (LVEF) values, is poorly investigated. According to the recent heart failure (HF) guidelines classified patients based on LVEF in HF with preserved ( HFpEF) mild reduced (HFmEF) and reduced LVEF ( HFrEF), the investigators would assess by seral clinical laboratory and detailed echocardiographic study all patients affected by chronic HF regardless LVEF threshold in stable condition and will follow by direct check up visit and/or virtual visits every 6 months for a mean follow-up period of 3 years. All clinical laboratory and echocardiographic data will be recorded in a web platform system accessible for all center included in the study The main aims of the study are; 1- to assess the incidence of RVH and RVD in each HF subtypes. 2- to evaluate prognostic impact ( in terms of cardiovascular mortality and HF hospitalization) of different RVD patterns during a mean followup period of 3 years 3- To investigate the incidence of different RV maladaptation ( isolated RV dilatation, isolated Pulmonary hypertension, combined pattern) in each HF groups and the related outcome. The investigators expect to find different RVD degree and severity according to the type of left HF and its severity. Additionally, by a serial multiparametric analysis of RV, it would be possible to establish the stage and type of RVD and consequent concordance with signs of RHF.

Conditions

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Chronic Heart Failure Right Ventricular Dysfunction Right Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF

The HFpEF group includes patients with signs and/or symptoms of heart failure and LVEF \> 50% and objective evidence of structural and/or functional cardiac abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' \> 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR \> 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.

Laboratory Test

Intervention Type DIAGNOSTIC_TEST

BNP, NT-proBNP and renal function.

HFmrEF

The HFmrEF group includes patients with signs and/or symptoms of heart failure and LVEF 41-49%.

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' \> 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR \> 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.

Laboratory Test

Intervention Type DIAGNOSTIC_TEST

BNP, NT-proBNP and renal function.

HFrEF

The HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF \< 40%.

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' \> 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR \> 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.

Laboratory Test

Intervention Type DIAGNOSTIC_TEST

BNP, NT-proBNP and renal function.

Interventions

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Echocardiography

Patients will undergo echocardiographic examination. The ejection fraction will be calculated using Simpson's method. The E/e' ratio will be measured using the Doppler method. E/e' \> 13 will be considered an expression of the increase in LVFP. TAPSE will be measured together with the peak tricuspid regurgitation velocity (TVR). Pulmonary arterial hypertension will be defined as TVR \> 2.8 m/s. Estimation of right atrial pressure (eRAP) will be obtained based on the diameter and inspiratory collapsibility of the inferior vena cava.

Intervention Type DIAGNOSTIC_TEST

Laboratory Test

BNP, NT-proBNP and renal function.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients with a diagnosis of chronic heart failure made according to the recommendations of the ESC guidelines through the simultaneous presence of signs and symptoms of disease associated with BNP and NT proBNP levels \> 100 and 300 pg/ml respectively which are associated with a modest increase PAPS \> 30 mmHg with or without right ventricular dilatation.

Exclusion Criteria

* Patients with dyspnea of non-cardiogenic origin, related to systemic respiratory diseases, pulmonary embolism, patients with primary pulmonary hypertension will be excluded.
* Patients with heart failure linked to primary valvular pathologies or infiltrative pathologies, secondary and on a genetic basis, patients diagnosed with acute heart failure in non-optimized therapy for at least 3 months will also be excluded. - Patients with systemic inflammatory neoplastic diseases, advanced liver and kidney diseases awaiting transplantation will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Society of Cardiology

OTHER

Sponsor Role collaborator

University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Alberto Palazzuoli MD PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Palazzuoli, MD

Role: STUDY_DIRECTOR

Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Siena

Locations

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Centro Cardiologico Monzino

Milan, Milano, Italy

Site Status

Department of Medicine, Surgery and Dentistry, Università di Salerno

Fisciano, Salerno, Italy

Site Status

SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia

Foggia, , Italy

Site Status

Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, University of Messina

Messina, , Italy

Site Status

Ospedale Sant'Agostino Milano

Milan, , Italy

Site Status

Department of Translational Medical Sciences, CIRCET

Napoli, , Italy

Site Status

Department of Translational Medical Sciences, Federico II University, CIRCET

Napoli, , Italy

Site Status

Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi

Napoli, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1

Pavia, , Italy

Site Status

S. Maria della Misericordia Hospital

Perugia, , Italy

Site Status

SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza

Potenza, , Italy

Site Status

Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses, Sapienza.

Roma, , Italy

Site Status

Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses.

Roma, , Italy

Site Status

Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Università degli Studi, Siena.

Siena, , Italy

Site Status

Countries

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Italy

Central Contacts

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Alberto Palazzuoli, MD

Role: CONTACT

+390577585363

Facility Contacts

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Pier Giuseppe Agostoni, MD

Role: primary

Michele Ciccarelli, MD

Role: primary

Michele Correale, MD

Role: primary

Giuseppe Dattilo, MD

Role: primary

Frank Dini, MD

Role: primary

Gabriele Tocchetti, MD

Role: primary

Valentina Mercurio, MD

Role: primary

Daniele Masarone, MD

Role: primary

Stefano Ghio, MD

Role: primary

Erberto Carluccio, MD

Role: primary

Pietro Mazzeo, MD

Role: primary

Paolo Severino, MD

Role: primary

Roberto Badagliaca, MD

Role: primary

Alberto Palazzuoli, MD

Role: primary

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Reference Type DERIVED
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Other Identifiers

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RIVED - CHF

Identifier Type: -

Identifier Source: org_study_id

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