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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Medical imaging
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring strain, MRI, echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult Patients with heart failure

Exclusion Criteria:

  • Renal failure
  • Contraindications to Cardiac MRI

Sites / Locations

  • Cliniques Universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Failure Patients

Arm Description

Patients with Heart Failure

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Heart Failure
Hospitalization due to heart failure

Full Information

First Posted
May 29, 2019
Last Updated
May 30, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Fonds National de la Recherche Scientifique
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1. Study Identification

Unique Protocol Identification Number
NCT03969394
Brief Title
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Acronym
RV-STRAIN
Official Title
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Fonds National de la Recherche Scientifique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives are 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. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
strain, MRI, echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Patients
Arm Type
Experimental
Arm Description
Patients with Heart Failure
Intervention Type
Diagnostic Test
Intervention Name(s)
Medical imaging
Intervention Description
Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Heart Failure
Description
Hospitalization due to heart failure
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult Patients with heart failure Exclusion Criteria: Renal failure Contraindications to Cardiac MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernhard Gerber, MD,PhD
Phone
+3227642803
Email
Bernhard.Gerber@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Gerber, MD,PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Gerber, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bernhard Gerber, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33438438
Citation
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.
Results Reference
derived

Learn more about this trial

The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease

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