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

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Dilated Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Ventriculo-arterial coupling assessment (R-V/A)

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).

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • University "G. d'Annunzio"
  • Milan, Italy
    • Niguarda Great Metropolitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Pulonary Hypertension; the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg	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).
Postcapillary Pulmonary Hypertension; PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) >15 mmHg	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).
combined postcapillary/precapillary Pulmonary Hypertension; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ITAB - Institute for Advanced Biomedical Technologies
• Investigators: Principal Investigator: Francesco Bianco, MD, Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: dilated cardiomyopathy; heart Failure; ventricular elastance; right heart systolic function; right ventriculo-arterial coupling
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: NGCH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No