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