NCT03405987

Brief Summary

The association of T1-mapping (both native and ECV) and strain analysis of LV and RV by CMR will be assessed. Results from strain analysis will be investigated in terms of their prognostic value.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

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

July 1, 2012

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

8.4 years

First QC Date

January 14, 2018

Last Update Submit

March 12, 2020

Conditions

Myocardial Fibrosis

Outcome Measures

Primary Outcomes (3)

  • Association of native LV T1-values and strain analysis

    Association of native LV T1-values and strain analysis by CMR

    Baseline

  • Association of ECV and strain analysis

    Association of ECV and strain analysis by CMR

    Baseline

  • Association of strain analysis and outcome

    Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)

    2 years

Study Arms (2)

ECV < median

Diagnostic Test: Strain analysis by CMR

ECV ≥ median

Diagnostic Test: Strain analysis by CMR

Interventions

Strain analysis by CMRDIAGNOSTIC_TEST

Strain analysis by CMR will be performed

ECV < medianECV ≥ median

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing CMR for whatever reason will be invited to participate. A specific subgroup of patients are heart failure with preserved ejection fraction.

You may qualify if:

  • undergoing CMR
  • willingness to participate

You may not qualify if:

  • \<18 years old
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Andreas Kammerlander, MD

CONTACT

014040046140andreas.kammerlander@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 14, 2018

First Posted

January 23, 2018

Study Start

July 1, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)