Assessment of Right Ventricular Function in Advanced Heart Failure

Completed

• Conditions: Dilated Cardiomyopathy; Heart Failure
• Interventions: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)

• Registration Number: NCT03893760
• Lead Sponsor: ITAB - Institute for Advanced Biomedical Technologies

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).

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).

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-03
• Study Completion: 2017-06
• Status Verified: 2019-03
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postcapillary Pulmonary Hypertension	Ventriculo-arterial coupling assessment (R-V/A)	PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) \>15 mmHg
No Pulonary Hypertension	Ventriculo-arterial coupling assessment (R-V/A)	the presence of mean pulmonary pressures (PAPm) at the right heart catheterization \< 25 mmHg
combined postcapillary/precapillary Pulmonary Hypertension	Ventriculo-arterial coupling assessment (R-V/A)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types	up to 24 weeks	Significant correlations and augmentation over PAPm and Pulmonay Hypertension

Secondary Outcome Measures

Name	Time	Method
Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment	up to 24 weeks	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

Trial Locations

Locations (2)

Niguarda Great Metropolitan Hospital; 🇮🇹 Milan, Italy

University "G. d'Annunzio"; 🇮🇹 Chieti, Italy