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出境医 / 临床实验 / The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease (RV-STRAIN)

The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease (RV-STRAIN)

Study Description
Brief Summary:

The objectives are

  1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.
  2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: Medical imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Heart Failure Patients
Patients with Heart Failure
 Diagnostic Test: Medical imaging
Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline
Outcome Measures
Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Heart Failure [ Time Frame: 3 years ]
    Hospitalization due to heart failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Patients with heart failure

Exclusion Criteria:

  • Renal failure
  • Contraindications to Cardiac MRI
Contacts and Locations

Contacts
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Contact: Bernhard Gerber, MD,PhD +3227642803 Bernhard.Gerber@uclouvain.be

Locations
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Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Bernhard Gerber, MD, PhD         
Principal Investigator: Bernhard Gerber, MD, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Fonds National de la Recherche Scientifique
Investigators
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Principal Investigator: Bernhard Gerber, MD,PhD Cliniques universitaires Saint-Luc
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019) 		overall survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019) 		Heart Failure [ Time Frame: 3 years ]
Hospitalization due to heart failure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Official Title  ICMJE The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Brief Summary

The objectives are

  1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.
  2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure
Intervention  ICMJE Diagnostic Test: Medical imaging
Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline
Study Arms  ICMJE Experimental: Heart Failure Patients
Patients with Heart Failure
Intervention: Diagnostic Test: Medical imaging
Publications * Houard L, Amzulescu MS, Colin G, Langet H, Militaru S, Rousseau MF, Ahn SA, Vanoverschelde JJ, Pouleur AC, Gerber BL. Prognostic Value of Pulmonary Transit Time by Cardiac Magnetic Resonance on Mortality and Heart Failure Hospitalization in Patients With Advanced Heart Failure and Reduced Ejection Fraction. Circ Cardiovasc Imaging. 2021 Jan;14(1):e011680. doi: 10.1161/CIRCIMAGING.120.011680. Epub 2021 Jan 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult Patients with heart failure

Exclusion Criteria:

  • Renal failure
  • Contraindications to Cardiac MRI
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969394
Other Study ID Numbers  ICMJE 2017/02MAR/117
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Fonds National de la Recherche Scientifique
Investigators  ICMJE
Principal Investigator: Bernhard Gerber, MD,PhD Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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