Clinical Trials Directory

Trials / Completed

CompletedNCT03893760

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
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
ITAB - Institute for Advanced Biomedical Technologies · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
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).

Timeline

Start date
2016-10-01
Primary completion
2017-03-01
Completion
2017-06-01
First posted
2019-03-28
Last updated
2019-03-29

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT03893760. Inclusion in this directory is not an endorsement.