MedDataX Logo

Assessment of Right Ventricular Function in Advanced Heart Failure

NCT ID: NCT03893760

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dilated Cardiomyopathy Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Pulonary Hypertension

the presence of mean pulmonary pressures (PAPm) at the right heart catheterization \< 25 mmHg

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

Intervention Type 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).

Postcapillary Pulmonary Hypertension

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

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

Intervention Type 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).

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.

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

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

* Refused informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ITAB - Institute for Advanced Biomedical Technologies

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Francesco Bianco

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francesco Bianco, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University "G. d'Annunzio"

Chieti, , Italy

Site Status

Niguarda Great Metropolitan Hospital

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NGCH001

Identifier Type: -

Identifier Source: org_study_id