Right Ventricular Dysfunction in Chronic Heart Failure (RIVED-CHF)

August 18, 2023 updated by: Alberto Palazzuoli MD PhD, University of Siena

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Foggia, Italy, 71121
        • SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia
        • Principal Investigator:
          • Michele Correale, MD
        • Contact:
      • Messina, Italy, 98125
        • Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, University of Messina
        • Contact:
        • Principal Investigator:
          • Giuseppe Dattilo, MD
      • Milano, Italy, 20127
        • Ospedale Sant'Agostino Milano
        • Contact:
        • Principal Investigator:
          • Frank Dini, MD
      • Napoli, Italy, 80131
        • Department of Translational Medical Sciences, CIRCET
        • Contact:
          • Gabriele Tocchetti, MD
        • Principal Investigator:
          • Gabriele Tocchetti, MD
      • Napoli, Italy, 80131
        • Department of Translational Medical Sciences, Federico II University, CIRCET
        • Contact:
          • Valentina Mercurio, MD
        • Principal Investigator:
          • Valentina Mercurio, MD
      • Napoli, Italy, 80131
        • Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi
        • Contact:
        • Principal Investigator:
          • Daniele Masarone, MD
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1
        • Principal Investigator:
          • Stefano Ghio, MD
        • Contact:
      • Perugia, Italy, 06100
        • S. Maria della Misericordia Hospital
        • Contact:
        • Principal Investigator:
          • Erberto Carluccio, MD
      • Potenza, Italy, 85100
        • SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza
        • Contact:
        • Principal Investigator:
          • Pietro Mazzeo, MD
      • Roma, Italy, 00161
        • Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses, Sapienza.
        • Contact:
        • Principal Investigator:
          • Paolo Severino, MD
      • Roma, Italy, 00161
        • Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses.
        • Contact:
        • Principal Investigator:
          • Roberto Badagliacca, MD
      • Siena, Italy, 53100
        • Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Università degli Studi, Siena.
        • Contact:
        • Principal Investigator:
          • Alberto Palazzuoli, MD
    • Milano
      • Milan, Milano, Italy, 20138
        • Centro Cardiologico Monzino
        • Contact:
        • Principal Investigator:
          • Pier Giuseppe Agostoni, MD
    • Salerno
      • Fisciano, Salerno, Italy, 84084
        • Department of Medicine, Surgery and Dentistry, Università di Salerno
        • Contact:
        • Principal Investigator:
          • Michele Ciccarelli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: Laboratory 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%.
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.
Diagnostic test: Laboratory Test
BNP, NT-proBNP and renal function.
HFrEF
The HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF < 40%.
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.
Diagnostic test: Laboratory Test
BNP, NT-proBNP and renal function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Different patterns of RVD in chronic heart failure.
Time Frame: 6 months.
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.
Time Frame: 6 months.
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.
Time Frame: 6 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define the incidence of RVD.
Time Frame: 6 months.
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.
Investigate a correlation between the different parameters.
Time Frame: 6 months.
Investigate a correlation between echo parameters, clinical signs and laboratory data.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Collaborators

Italian Society of Cardiology

Investigators

  • Study Director: Alberto Palazzuoli, MD, Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Siena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIVED - CHF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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