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Trial record 87 of 157 for:    Idiopathic Dilated Cardiomyopathy

Assessment of Right Ventricular Function in Advanced Heart Failure

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ClinicalTrials.gov Identifier: NCT03893760
Recruitment Status : Completed
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Francesco Bianco, 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).

Condition or disease Intervention/treatment
Dilated Cardiomyopathy Heart Failure Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)

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).

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Right Ventricular Function in Advanced Heart Failure: Feasibility and Reliability of Right Ventricular Elastance
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 2017


Group/Cohort Intervention/treatment
No Pulonary Hypertension
the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg
Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).

Postcapillary Pulmonary Hypertension
PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) >15 mmHg
Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).

combined postcapillary/precapillary Pulmonary Hypertension
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.
Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893760


Locations
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Italy
University "G. d'Annunzio"
Chieti, Italy, 66100
Niguarda Great Metropolitan Hospital
Milan, Italy
Sponsors and Collaborators
ITAB - Institute for Advanced Biomedical Technologies
Investigators
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Principal Investigator: Francesco Bianco, MD Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy

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Responsible Party: Francesco Bianco, Principal Investigator, ITAB - Institute for Advanced Biomedical Technologies
ClinicalTrials.gov Identifier: NCT03893760     History of Changes
Other Study ID Numbers: NGCH001
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies:
heart Failure
ventricular elastance
dilated cardiomyopathy
right heart systolic function
right ventriculo-arterial coupling
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly