NCT03405051

Brief Summary

Hypokalemia is very common in heart failure patients. Deleterious effects have been report on the cardiovascular system. Most of the clinical data concerning this ionic trouble are based on post-hoc study and some findings seemed disjointed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 4, 2019

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

January 12, 2018

Last Update Submit

February 1, 2019

Conditions

Heart Failure

Keywords

hypokalemiacardiac failure

Outcome Measures

Primary Outcomes (1)

  • Composite of death and re-hospitalization

    The number of death for any reason and re-hospitalization for congestive heart failure

    Month 3

Secondary Outcomes (5)

  • Death

    Month 3

  • Re-hospitalization

    Month 3

  • Length of stay

    Month 3

  • Incidence of hypokalemia

    Month 3

  • Prevalence of hypokalemia

    Month 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with congestive heart failure admitted to the Heart Failure Unit in the Mercy hospital (CHR Metz-Thionville).

You may qualify if:

  • Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville
  • Patient with congestive heart failure

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Heart FailureHypokalemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

November 15, 2017

Primary Completion

November 15, 2018

Study Completion

February 1, 2019

Last Updated

February 4, 2019

Record last verified: 2017-12

Locations

FR(1)