Assessment of Right Ventricular Function in Advanced Heart Failure

Study Overview
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Brief Summary
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We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP).

Detailed Description
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This is a single center, retrospective cross-sectional study. In 2016-17, for 6 months, we evaluated for eligibility 81 consecutive D-CMP patients afferent to Niguarda Great Metropolitan Hospital for RHC and echocardiography. All participants underwent the exams in the context of heart-transplant or advanced HF evaluation. Inclusion criteria were: 18 years old, given informed consent, D-CMP, New York Heart Association (NYHA) functional class II or III and reduced EF (≤ 35%). On the contrary, exclusion criteria were: missing the inclusion criteria and refused informed consent. The final sample consisted of 68 study participants (mean age 64±7 years, 82 % male).

Official Title
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Assessment of Right Ventricular Function in Advanced Heart Failure: Feasibility and Reliability of Right Ventricular Elastance

Conditions
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Dilated Cardiomyopathy, Heart Failure

Intervention / Treatment
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* Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old Given informed consent D-CMP New York Heart Association (NYHA) functional class II or III Reduced EF (≤ 35%) Exclusion Criteria: Missing the inclusion criteria Refused informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Pulonary Hypertension<br>the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg | Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)<br>* R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).<br>|
| Postcapillary Pulmonary Hypertension<br>PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) >15 mmHg | Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)<br>* R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).<br>|
| combined postcapillary/precapillary Pulmonary Hypertension<br>PAPm ≥ 25 mmHg, PAWP >15 mmHg and diastolic peak gradient (DPG - diastolic pulmonary pressure - PCWP) ≥7 mmHg and/or pulmonary vascular resistence (PVR) >3 WU, where available. | Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)<br>* R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types | Significant correlations and augmentation over PAPm and Pulmonay Hypertension | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment | Two independent physicians, both experts in echocardiography, independently re-examined 40 studies, randomly selected from all the acquired echocardiographic images. In order to test the R-V/A coupling interobserver agreement | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart Failure, ventricular elastance, dilated cardiomyopathy, right heart systolic function, right ventriculo-arterial coupling