Right Ventricular Dysfunction in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

— RIVED-CHF  

Official title:

Right Ventricular Dysfunction in Chronic Heart Failure: Clinical Laboratory and Echocardiographic Characteristics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002321
• Other study ID #: RIVED - CHF
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: August 2023
• Source: University of Siena
• Contact: Alberto Palazzuoli, MD
• Phone: +390577585363
• Email: palazzuoli2[@]unisi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Right Heart Failure
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• 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.
• Laboratory Test
BNP, NT-proBNP and renal function.

Locations

Country	Name	City	State
Italy	Department of Medicine, Surgery and Dentistry, Università di Salerno	Fisciano	Salerno
Italy	SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia	Foggia
Italy	Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, University of Messina	Messina
Italy	Centro Cardiologico Monzino	Milan	Milano
Italy	Ospedale Sant'Agostino Milano	Milano
Italy	Department of Translational Medical Sciences, CIRCET	Napoli
Italy	Department of Translational Medical Sciences, Federico II University, CIRCET	Napoli
Italy	Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi	Napoli
Italy	Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1	Pavia
Italy	S. Maria della Misericordia Hospital	Perugia
Italy	SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza	Potenza
Italy	Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses, Sapienza.	Roma
Italy	Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses.	Roma
Italy	Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Università degli Studi, Siena.	Siena

Sponsors (2)

Lead Sponsor	Collaborator
University of Siena	Italian Society of Cardiology

Country where clinical trial is conducted

Italy, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Define the incidence of RVD.	To define the incidence of RVD through a multiparametric echocardiographic analysis including all the echocardiographic parameters of right ventricular function in order to identify a precise score based on the simultaneous dysfunction of several parameters.	6 months.
Secondary	Investigate a correlation between the different parameters.	Investigate a correlation between echo parameters, clinical signs and laboratory data.	6 months.