Right Ventricular Dysfunction in Chronic Heart Failure

NCT06002321 | Not Yet Recruiting

• 1 other identifier: RIVED - CHF
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

Brief Summary

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. 1.to assess the incidence of RVH and RVD in each HF subtypes.
2. 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. 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.

Conditions

Chronic Heart Failure; Right Ventricular Dysfunction; Right Heart Failure

Outcome Measures

Primary Outcomes (3)

• Different patterns of RVD in chronic heart failure.

  The different patterns of RVD will be evaluated with echocardiographic measurements. Right ventricular function will be assessed by the following echocardiographic parameters: tricuspid annular plane excursion (TAPSE) and right ventricular fractional area change (RVFAC).

  6 months.

• Analyze the incidence and prevalence of RVD and RHF.

  To analyze the incidence and prevalence of RVD and RHF according to left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF).

  6 months.

• Compare the clinical signs of right heart failure with the echocardiographic signs of RVD.

  Compare clinical signs of right heart failure with echocardiographic parameters of right ventricular dysfunction in order to verify agreement and identify a precise relationship between RHF and RVD.

  6 months.

Secondary Outcomes (2)

• Define the incidence of RVD.

  6 months.

• Investigate a correlation between the different parameters.

  6 months.

Study Arms (3)

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.

Diagnostic Test: Echocardiography; Diagnostic Test: Laboratory Test

HFmrEF

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

Diagnostic Test: Echocardiography; Diagnostic Test: Laboratory Test

HFrEF

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

Diagnostic Test: Echocardiography; Diagnostic Test: Laboratory Test

Interventions

Echocardiography 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.

HFmrEF; HFpEF; HFrEF

Laboratory Test DIAGNOSTIC_TEST

BNP, NT-proBNP and renal function.

HFmrEF; HFpEF; HFrEF

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with chronic heart failure will be consecutively enrolled prospectively in different cities. The diagnosis will be made on the basis of the signs and symptoms of the disease associated with BNP and NT-proBNP levels. Patients will be classified according to the type of cardiac structure and remodeling defect and ejection fraction.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead
• Italian Society of Cardiology: collaborator

Study Sites (14)

Centro Cardiologico Monzino

Milan, Milano, 20138, Italy

Location

Department of Medicine, Surgery and Dentistry, Università di Salerno

Fisciano, Salerno, 84084, Italy

Location

SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia

Foggia, 71121, Italy

Location

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

Messina, 98125, Italy

Location

Ospedale Sant'Agostino Milano

Milan, 20127, Italy

Location

Department of Translational Medical Sciences, CIRCET

Napoli, 80131, Italy

Location

Department of Translational Medical Sciences, Federico II University, CIRCET

Napoli, 80131, Italy

Location

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

Napoli, 80131, Italy

Location

Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1

Pavia, 27100, Italy

Location

S. Maria della Misericordia Hospital

Perugia, 06100, Italy

Location

SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza

Potenza, 85100, Italy

Location

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

Roma, 00161, Italy

Location

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

Roma, 00161, Italy

Location

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

Siena, 53100, Italy

Location

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MeSH Terms

Conditions

Ventricular Dysfunction, Right; Heart Failure

Interventions

Echocardiography; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Investigative Techniques

Study Officials

• Alberto Palazzuoli, MD

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

  STUDY DIRECTOR

Central Study Contacts

Alberto Palazzuoli, MD

CONTACT

+390577585363; palazzuoli2@unisi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (14)