Assessment of Right Ventricular Function in Advanced Heart Failure

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Brief Title

Assessment of Right Ventricular Function in Advanced Heart Failure

Official Title

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

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 Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Dilated Cardiomyopathy

Intervention

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

Study Arms / Comparison Groups

 No Pulonary Hypertension
Description:  the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

60

Start Date

October 2016

Completion Date

June 2017

Primary Completion Date

March 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Francesco Bianco, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT03893760

Organization ID

NGCH001


Responsible Party

Principal Investigator

Study Sponsor

ITAB - Institute for Advanced Biomedical Technologies


Study Sponsor

Francesco Bianco, MD, Principal Investigator, Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy


Verification Date

March 2019