Assessment of Right Ventricular Function in Advanced Heart Failure

ITAB - Institute for Advanced Biomedical Technologies

Status: Completed

Conditions: Heart Failure; Dilated Cardiomyopathy

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

Study type: Observational

Funder types: Other

Identifiers

NCT03893760

NGCH001

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

No Pulonary Hypertension

Description:

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

Treatment:

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

Postcapillary Pulmonary Hypertension

Description:

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

Treatment:

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

combined postcapillary/precapillary Pulmonary Hypertension

Description:

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.

Treatment:

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