Hypokalemia in Hospitalized Patients for Heart Failure in... | NCT03405051

Studies
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit

NCT03405051

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2017Actual

Primary Completion Date

Nov 15, 2018Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Jan 12, 2018

First Submission Date that Met QC Criteria

Jan 12, 2018

First Posted Date

Jan 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study tried to describe hypokalemia impact during hospital stay in hospitalized patients with heart failure and particularly on mortality and re-hospitalization.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of death and re-hospitalization	The number of death for any reason and re-hospitalization for congestive heart failure	Month 3

Secondary Outcomes

Measure	Description	Time Frame
Death	Percentage of death for any reason	Month 3
Re-hospitalization	Percentage of re-hospitalization for congestive heart failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz-Thionville		Metz		57085	France

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D007008	Hypokalemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided