Assessment of Right Ventricular Function in Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893760
• Other study ID #: NGCH001
• Status: Completed
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: ITAB - Institute for Advanced Biomedical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure

Intervention

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).

Locations

Country	Name	City	State
Italy	University "G. d'Annunzio"	Chieti
Italy	Niguarda Great Metropolitan Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
ITAB - Institute for Advanced Biomedical Technologies

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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