NCT03372512

Brief Summary

It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging. In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration 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

First Submitted

Initial submission to the registry

December 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 8, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

December 7, 2017

Last Update Submit

August 12, 2019

Conditions

Heart DiseasesHeart FailureValvular Heart Disease

Outcome Measures

Primary Outcomes (2)

  • Native T1-mapping

    Association of fluid overload and native T1 values of left ventricular myocardium

    baseline

  • Extracellular Volume by Cardiovascular magnetic resonance imaging

    Association of fluid overload and extracellular volume of left ventricular myocardium

    baseline

Study Arms (2)

Fluid overload (Liters) ≥ median

Diagnostic Test: Bioimpedance spectroscopy

Fluid overload (Liters) < median

Diagnostic Test: Bioimpedance spectroscopy

Interventions

Bioimpedance spectroscopyDIAGNOSTIC_TEST

Fluid overload will be assessed by bioimpedance spectroscopy

Also known as: BCM measurement
Fluid overload (Liters) < medianFluid overload (Liters) ≥ median

Eligibility Criteria

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

Patients undergoing cardiovascular magnetic resonance imaging including T1-mapping are invited to participate in the study where fluid status will be assessed by bioimpedance spectroscopy right before cardiovascular magnetic resonance imaging.

You may qualify if:

  • written informed consent
  • patient undergoing cardiovascular magnetic resonance imaging

You may not qualify if:

  • Unwillingness to participate
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Heart DiseasesHeart FailureHeart Valve Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Andreas Kammerlander, MD PhD

CONTACT

004314040046140andreas.kammerlander@meduniwien.ac.at

Study Design

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

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 13, 2017

Study Start

May 8, 2018

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

AU(1)