Heart FailureHYPICNCT03405051
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit
An observational study of Heart Failure, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2017to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with congestive heart failure admitted to the Heart Failure Unit in the Mercy hospital (CHR Metz-Thionville).
Who may be able to join
- Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville
- Patient with congestive heart failure
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit: Morbidity-mortality Impact
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- hypokalemia, cardiac failure
- Medical subject headings
- Heart Failure, Hypokalemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death and re-hospitalization
The number of death for any reason and re-hospitalization for congestive heart failure
Measured: Month 3
Secondary outcomes (5)
Death
Percentage of death for any reason
Measured: Month 3
Re-hospitalization
Percentage of re-hospitalization for congestive heart failure
Measured: Month 3
Length of stay
Days spent at the hospital
Measured: Month 3
Incidence of hypokalemia
Percentage of incidence during the stay of hypokalemia
Measured: Month 3
Prevalence of hypokalemia
Percentage of initial prevalence during the stay of hypokalemia
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start15 Nov 2017
- Primary completion15 Nov 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405051
- Sponsor's protocol ID
- 2017-03Obs-CHRMT
- Acronym
- HYPIC
- Status last verified
- Dec 2017
- First submitted
- 12 Jan 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit: Morbidity-mortality Impact
- ClinicalTrials.gov ID
- NCT03405051
- Acronym / sponsor ID
- HYPIC / 2017-03Obs-CHRMT
- Conditions
- Heart Failure
- Keywords
- hypokalemia, cardiac failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with congestive heart failure admitted to the Heart Failure Unit in the Mercy hospital (CHR Metz-Thionville).
Key inclusion criteria (2 listed)
- Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville
- Patient with congestive heart failure
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of death and re-hospitalization
Time frame: Month 3
The number of death for any reason and re-hospitalization for congestive heart failure
5 secondary outcomes
Death
Time frame: Month 3
Re-hospitalization
Time frame: Month 3
Length of stay
Time frame: Month 3
Incidence of hypokalemia
Time frame: Month 3
Prevalence of hypokalemia
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death and re-hospitalization (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.