Assessment of Right Ventricular Function in Advanced Heart Failure

NCT03893760 | Completed DMC

• 1 other identifier: NGCH001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Dilated Cardiomyopathy; Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 24 weeks

Study Arms (3)

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)

Postcapillary Pulmonary Hypertension

PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) \>15 mmHg

Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)

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)

Interventions

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).

No Pulonary Hypertension; Postcapillary Pulmonary Hypertension; combined postcapillary/precapillary Pulmonary Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years old
• Given informed consent
• D-CMP
• New York Heart Association (NYHA) functional class II or III
• Reduced EF (≤ 35%)

You may not qualify if:

• Refused informed consent

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies: lead

Study Sites (2)

University "G. d'Annunzio"

Chieti, 66100, Italy

Location

Niguarda Great Metropolitan Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Francesco Bianco, MD

  Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)