The Prognostic Role of the Right Ventricle in Patients Wi... | NCT03969394

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

NCT03969394

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

May 31, 2019Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Medical imaging

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Sep 30, 2020Estimated

First Submitted Date

May 29, 2019

First Submission Date that Met QC Criteria

May 30, 2019

First Posted Date

May 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2019

Last Update Posted Date

May 31, 2019Actual

Name	Class
Fonds National de la Recherche Scientifique	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart Failure Patients	Experimental	Patients with Heart Failure	Diagnostic Test: Medical imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical imaging	Diagnostic Test	Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline	Heart Failure Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival		3 years

Secondary Outcomes

Measure	Description	Time Frame
Heart Failure	Hospitalization due to heart failure	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Patients with heart failure

Exclusion Criteria:

Renal failure
Contraindications to Cardiac MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bernhard Gerber, MD,PhD	Contact	+3227642803		Bernhard.Gerber@uclouvain.be

Overall Officials

Name	Affiliation	Role
Bernhard Gerber, MD,PhD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint-Luc	Recruiting	Brussels		1200	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33438438	Derived	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.

ID	Term
D006333	Heart Failure
D013180	Sprains and Strains

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014947	Wounds and Injuries

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis