An observational study in Dilated Cardiomyopathy and Heart Failure, sponsored by ITAB - Institute for Advanced Biomedical Technologies. Completed at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by ITAB - Institute for Advanced Biomedical Technologies · Observational
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).
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).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →ITAB - Institute for Advanced Biomedical Technologies is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.
Exclusion Criteria:
the presence of mean pulmonary pressures (PAPm) at the right heart catheterization \< 25 mmHg
Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) \>15 mmHg
Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
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)
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).
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
Time frame: up to 24 weeks
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
Time frame: up to 24 weeks
Plan to share: No
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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ITAB - Institute for Advanced Biomedical Technologies