NCT03969394

Brief Summary

The objectives are

  1. 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. 2.to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

3.3 years

First QC Date

May 29, 2019

Last Update Submit

May 30, 2019

Conditions

Heart Failure

Keywords

strainMRIechocardiography

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Secondary Outcomes (1)

  • Heart Failure

    3 years

Study Arms (1)

Heart Failure Patients

EXPERIMENTAL

Patients with Heart Failure

Diagnostic Test: Medical imaging

Interventions

Medical imagingDIAGNOSTIC_TEST

Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline

Heart Failure Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patients with heart failure

You may not qualify if:

  • Renal failure
  • Contraindications to Cardiac MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33438438DERIVED

MeSH Terms

Conditions

Heart FailureSprains and Strains

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Bernhard Gerber, MD,PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Gerber, MD,PhD

CONTACT

+3227642803Bernhard.Gerber@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

June 1, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)