Heart FailureNCT04845126
Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit
An observational study of Heart Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 25 Dec 2021
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for heart failure or with known heart failure in our Internal Medecine unit between 2016/01/01 and 2018/01/01.
Who may be able to join
- Patients hospitalized in our Internal Medecine unit for acute heart failure or for another cause but with known chronic heart Failure
Who cannot join
- Hemodilaysis, end stage kidney disease, heart failure cause by anuria, heart transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit - a Four Years Follow-up Study
In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017).
The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge.
Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.
- Conditions
- Heart Failure
- Keywords
- Outcomes, Internal medecine, Heart failure treatment, Heart failure guidelines, quality of life
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
re-hospitalization for heart failure or death failure assessed by spirometry
re-hospitalization for heart failure or death (yes or no) (composite outcome)
Measured: 1 day
Secondary outcomes (4)
time to re-hospitalization
time to re-hospitalization
Measured: 1 day
time to death
time to death
Measured: 1 day
cause of hospitalization
cause of hospitalization
Measured: 1 day
cause of death
cause of death
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Apr 2021
- Study completion25 Dec 2021
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Fesler, PUPH, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845126
- Sponsor's protocol ID
- RECHMPL21_0188
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit - a Four Years Follow-up Study
- ClinicalTrials.gov ID
- NCT04845126
- Acronym / sponsor ID
- RECHMPL21_0188
- Conditions
- Heart Failure
- Keywords
- Outcomes, Internal medecine, Heart failure treatment, Heart failure guidelines, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 14 Apr 2021 (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.
In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017).
The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge.
Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for heart failure or with known heart failure in our Internal Medecine unit between 2016/01/01 and 2018/01/01.
Key inclusion criteria (1 listed)
- Patients hospitalized in our Internal Medecine unit for acute heart failure or for another cause but with known chronic heart Failure
Key exclusion criteria (1 listed)
- Hemodilaysis, end stage kidney disease, heart failure cause by anuria, heart transplantation
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
re-hospitalization for heart failure or death failure assessed by spirometry
Time frame: 1 day
re-hospitalization for heart failure or death (yes or no) (composite outcome)
4 secondary outcomes
time to re-hospitalization
Time frame: 1 day
time to death
Time frame: 1 day
cause of hospitalization
Time frame: 1 day
cause of death
Time frame: 1 day
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 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pierre Fesler, PUPH study director
UH MONTPELLIER
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 University Hospital, Montpellier 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 1 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 14 Apr 2022. 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?
re-hospitalization for heart failure or death failure assessed by spirometry (time frame: 1 day). 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 14 Apr 2022.