Right Ventricular Dysfunction in Chronic Heart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Siena
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Echocardiography
Diagnostic testPatients 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
Diagnostic testBNP, NT-proBNP and renal function.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: HFpEF2 interventions
Group B: HFmrEF2 interventions
Group C: HFrEF2 interventions
Trial outcomes
Primary outcomes
1
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.2
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.3
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.Secondary outcomes
1
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.2
Investigate a correlation between the different parameters.
Investigate a correlation between echo parameters, clinical signs and laboratory data.
Time frame
6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Siena
Lead sponsor
Italian Society of Cardiology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: