NCT03371394

Brief Summary

By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.

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 Dec 2017

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
2 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
3 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

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

December 7, 2017

Last Update Submit

August 12, 2019

Conditions

Valvular Heart DiseaseFluid OverloadCardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular outcome

    composition of hospitalization due to heart failure and cardiovascular death

    3 years

Secondary Outcomes (4)

  • Severity of valvular heart disease

    baseline

  • NT-proBNP

    baseline

  • Clinical status (NYHA functional class)

    baseline

  • Renal impairment

    baseline

Study Arms (2)

median 1

Other: no intervention

median 2

Other: no intervention

Interventions

no interventionOTHER

no intervention

median 1median 2

Eligibility Criteria

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

Patients Valvular stenosis and/or regurgitation of all severities assessed by current recommendations are eligible for this study.

You may qualify if:

  • Valvular stenosis and/or regurgitation of all severities as defined by current recommendations
  • informed consent
  • willingness to perform follow up visit

You may not qualify if:

  • \<18 years old
  • pregnancy
  • unwillingness to paricipate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Heart Valve DiseasesEdema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Andreas Kammerlander, MD

CONTACT

004314040046140andreas.kammerlander@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
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

December 15, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)