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Assessment of Right Ventricular Function in Advanced Heart Failure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03893760
Enrollment
60
Registered
2019-03-28
Start date
2016-10-31
Completion date
2017-06-30
Last updated
2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy, Heart Failure

Keywords

heart Failure, ventricular elastance, dilated cardiomyopathy, right heart systolic function, right ventriculo-arterial coupling

Brief summary

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

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).

Interventions

DIAGNOSTIC_TESTVentriculo-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).

Sponsors

ITAB - Institute for Advanced Biomedical Technologies
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension typesup to 24 weeksSignificant correlations and augmentation over PAPm and Pulmonay Hypertension

Secondary

MeasureTime frameDescription
Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessmentup to 24 weeksTwo 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026