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Clinical Trials/NCT03893760
NCT03893760
Completed
N/A

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

ITAB - Institute for Advanced Biomedical Technologies2 sites in 1 country60 target enrollmentOctober 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dilated Cardiomyopathy
Sponsor
ITAB - Institute for Advanced Biomedical Technologies
Enrollment
60
Locations
2
Primary Endpoint
Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
June 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ITAB - Institute for Advanced Biomedical Technologies
Responsible Party
Principal Investigator
Principal Investigator

Francesco Bianco

Principal Investigator

ITAB - Institute for Advanced Biomedical Technologies

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Missing the inclusion criteria
  • Refused informed consent

Outcomes

Primary Outcomes

Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types

Time Frame: up to 24 weeks

Significant correlations and augmentation over PAPm and Pulmonay Hypertension

Secondary Outcomes

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

Study Sites (2)

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