An observational study in Chronic Heart Failure, Right Ventricular Dysfunction and Right Heart Failure, sponsored by University of Siena. Not yet recruiting at 14 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by University of Siena · Observational
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:
Participants will follow by direct check up visit and/or virtual visits every 6 months for a mean follow-up period of 3 years.
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.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Diagnostic Test: Laboratory Test
The HFmrEF group includes patients with signs and/or symptoms of heart failure and LVEF 41-49%.
Diagnostic Test: Echocardiography · Diagnostic Test: Laboratory Test
The HFrEF group includes patients with signs and/or symptoms of heart failure and LVEF \< 40%.
Diagnostic Test: Echocardiography · Diagnostic Test: Laboratory Test
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.
BNP, NT-proBNP and renal function.
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).
Time frame: 6 months.
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).
Time frame: 6 months.
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.
Time frame: 6 months.
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.
Time frame: 6 months.
Investigate a correlation between the different parameters.
Investigate a correlation between echo parameters, clinical signs and laboratory data.
Time frame: 6 months.
Plan to share: No
Start is estimated for Sep 2023; primary completion for Mar 2024, 6 months later.
Of 25 observational studies under Ventricular Dysfunction, Right, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Siena