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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

Tracking Information
First Submitted Date March 26, 2019
First Posted Date March 28, 2019
Last Update Posted Date March 28, 2019
Actual Study Start Date October 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2019)
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
Original Primary Outcome Measures
 (submitted: March 27, 2019)
Right ventriculo/arterial (R-V/A) coupling feasibility [ Time Frame: up to 24 weeks ]
Significant correlations and augmentation over PAPm and Pulmonay Hypertension
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 27, 2019)
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
Original Secondary Outcome Measures
 (submitted: March 27, 2019)
Reliability of 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.
Condition
  • Dilated Cardiomyopathy
  • Heart Failure
Intervention 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).
Study Groups/Cohorts
  • No Pulonary Hypertension
    the presence of mean pulmonary pressures (PAPm) at the right heart catheterization < 25 mmHg
    Intervention: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
  • Postcapillary Pulmonary Hypertension
    PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) >15 mmHg
    Intervention: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
  • 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.
    Intervention: Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 27, 2019)
60
Original Actual Enrollment Same as current
Actual Study Completion Date June 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03893760
Other Study ID Numbers NGCH001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies
Study Sponsor ITAB - Institute for Advanced Biomedical Technologies
Collaborators Not Provided
Investigators
Principal Investigator: Francesco Bianco, MD Institute of Cardiology - University "G. d'Annunzio" - Chieti, Italy
PRS Account ITAB - Institute for Advanced Biomedical Technologies
Verification Date March 2019