Right Ventricular Dysfunction in Chronic Heart Failure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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 coll
• Диагностический тест Laboratory Test
  BNP, NT-proBNP and renal function.

Первичные конечные точки

• Different patterns of RVD in chronic heart failure. [Срок оценки: 6 months.]
• Analyze the incidence and prevalence of RVD and RHF. [Срок оценки: 6 months.]
• Compare the clinical signs of right heart failure with the echocardiographic signs of RVD. [Срок оценки: 6 months.]

Вторичные конечные точки (2)

• Define the incidence of RVD. [Срок оценки: 6 months.]
• Investigate a correlation between the different parameters. [Срок оценки: 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 14 центров

• Centro Cardiologico Monzino — Milan
• Department of Medicine, Surgery and Dentistry, Università di Salerno — Fisciano
• SC Universitaria di Cardiologia - UTIC Policlinico Riuniti Foggia — Foggia
• Department of Clinical and Experimental Medicine, Operativee Unit of Cardiology, Universit — Messina
• Ospedale Sant'Agostino Milano — Milan
• Department of Translational Medical Sciences, CIRCET — Naples
• Department of Translational Medical Sciences, Federico II University, CIRCET — Naples
• Heart Failure Unit, Department of Cardiology, AORN dei Colli-Monaldi — Naples
• … и ещё 6 центров

Публикации

• Furey SA 3rd, Zieske HA, Levy MN. The essential function of the right ventricle. Am Heart J. 1984 Feb;107(2):404-10. doi: 10.1016/0002-8703(84)90402-2. No abstract available. PMID 6695680
• Poels EM, da Costa Martins PA, van Empel VP. Adaptive capacity of the right ventricle: why does it fail? Am J Physiol Heart Circ Physiol. 2015 Apr 15;308(8):H803-13. doi: 10.1152/ajpheart.00573.2014. Epub 2015 Feb 13. PMID 25681425
• Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available. PMID 18378625
• Meyer P, Filippatos GS, Ahmed MI, Iskandrian AE, Bittner V, Perry GJ, White M, Aban IB, Mujib M, Dell'Italia LJ, Ahmed A. Effects of right ventricular ejection fraction on outcomes in chronic systolic heart failure. Circulation. 2010 Jan 19;121(2):252-8. doi: 10.1161/CIRCULATIONAHA.109.887570. Epub 2010 Jan 4. PMID 20048206
• Voelkel NF, Gomez-Arroyo J, Abbate A, Bogaard HJ. Mechanisms of right heart failure-A work in progress and a plea for failure prevention. Pulm Circ. 2013 Jan;3(1):137-43. doi: 10.4103/2045-8932.109957. No abstract available. PMID 23662190
• Markel TA, Wairiuko GM, Lahm T, Crisostomo PR, Wang M, Herring CM, Meldrum DR. The right heart and its distinct mechanisms of development, function, and failure. J Surg Res. 2008 May 15;146(2):304-13. doi: 10.1016/j.jss.2007.04.003. Epub 2007 Nov 26. PMID 18036544
• Ghio S, Acquaro M, Agostoni P, Ambrosio G, Carluccio E, Castiglione V, Colombo D, D'Alto M, Delle Grottaglie S, Dini FL, Emdin M, Fortunato M, Guaricci AI, Jacoangeli F, Marra AM, Paolillo S, Papa S, Scajola LV, Correale M, Palazzuoli A. Right heart failure in left heart disease: imaging, functional, and biochemical aspects of right ventricular dysfunction. Heart Fail Rev. 2023 Jul;28(4):1009-1022 PMID 36385328
• de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4. PMID 9768716

Идентификаторы

NCT: NCT06002321 · RIVED - CHF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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