Assessment of Right Ventricular Function in Advanced Heart Failure

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).

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University "G. d'Annunzio", Chieti, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventriculo-arterial coupling assessment (R-V/A)

Diagnostic Test

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).

Primary outcomes

Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types

Time frame: up to 24 weeks

Significant correlations and augmentation over PAPm and Pulmonay Hypertension

Secondary outcomes

Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment

Time frame: up to 24 weeks

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

Sponsors and collaborators

Lead sponsor

ITAB - Institute for Advanced Biomedical Technologies

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 28, 2019
Registry last updated: Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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