Study Results
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Basic Information
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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2023-09-01
2026-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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
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.
HFmrEF
The HFmrEF group includes patients with signs and/or symptoms of heart failure and LVEF 41-49%.
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.
HFrEF
The HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF \< 40%.
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.
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.
Laboratory Test
BNP, NT-proBNP and renal function.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Italian Society of Cardiology
OTHER
University of Siena
OTHER
Responsible Party
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Alberto Palazzuoli MD PhD
Professor
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
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
Ospedale Sant'Agostino Milano
Milan, , 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, , Italy
Countries
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Central Contacts
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Facility Contacts
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Gabriele Tocchetti, MD
Role: primary
Valentina Mercurio, MD
Role: primary
References
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Other Identifiers
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RIVED - CHF
Identifier Type: -
Identifier Source: org_study_id
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