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RIVED-CHF: Right Ventricular Dysfunction in Chronic Heart Failure

Sponsor
University of Siena (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06002321
Collaborator
Italian Society of Cardiology (Other)
1,000
Enrollment
14
Locations
36
Anticipated Duration (Months)
71.4
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiography
  • Diagnostic Test: Laboratory Test

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Right Ventricular Dysfunction in Chronic Heart Failure: Clinical Laboratory and Echocardiographic Characteristics
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Different patterns of RVD in chronic heart failure. [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).

  2. Analyze the incidence and prevalence of RVD and RHF. [6 months.]

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

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

Secondary Outcome Measures

  1. Define the incidence of RVD. [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.

  2. Investigate a correlation between the different parameters. [6 months.]

    Investigate a correlation between echo parameters, clinical signs and laboratory data.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Cardiologico Monzino Milan Milano Italy 20138
2 Department of Medicine, Surgery and Dentistry, Università di Salerno Fisciano Salerno Italy 84084
3 SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia Foggia Italy 71121
4 Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, University of Messina Messina Italy 98125
5 Ospedale Sant'Agostino Milano Milano Italy 20127
6 Department of Translational Medical Sciences, CIRCET Napoli Italy 80131
7 Department of Translational Medical Sciences, Federico II University, CIRCET Napoli Italy 80131
8 Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi Napoli Italy 80131
9 Fondazione IRCCS Policlinico San Matteo - Pavia UOC Cardiologia 1 Pavia Italy 27100
10 S. Maria della Misericordia Hospital Perugia Italy 06100
11 SC Cardiologia, Azienda Ospedaliera Ospedale San Carlo Potenza Potenza Italy 85100
12 Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses, Sapienza. Roma Italy 00161
13 Cardiology, Department of Clinica, Internal, Anesthesiology and Cardiovascular Scienses. Roma Italy 00161
14 Unità di Malattie Cardiovascolari, Dipartimento Cardio-Toraco-Vascolare AOUS, Università degli Studi, Siena. Siena Italy 53100

Sponsors and Collaborators

  • University of Siena
  • Italian Society of Cardiology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alberto Palazzuoli MD PhD, Professor, University of Siena
ClinicalTrials.gov Identifier:
NCT06002321
Other Study ID Numbers:
  • RIVED - CHF
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Right

Study Results

No Results Posted as of Aug 21, 2023