Heart FailurePATHWAY-HFNCT06338878
PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes
An observational study of Heart Failure, run by Pr. Nicolas GIRERD at 1 site in France.
Trial summary
This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for cardiac decompensation in the cardiology department of CHRU of Nancy,
Who may be able to join
- Man or women ≥ 18 years
- Patients hospitalized for cardiac decompensation (ESC 2016 and 2021 criteria)
Who cannot join
- Patient expressing refusal to participate in research
- Patient who is a minor or under administrative protection
- Pregnant women
- Patient with ventricular assistance
- Patient with congenital heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy
Laura FILIPPETTI, l.filippetti@chru-nancy.fr
About this study
This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause post-hospitalization mortality
Composite endpoint of all-cause post-hospitalization mortality and rehospitalization for heart failure with outcome 2
Measured: Within 1 year following hospital discharge
Rehospitalization for heart failure
Composite endpoint of all-cause post-hospitalization mortality and rehospitalization for heart failure with outcome 1
Measured: Within 1 year following hospital discharge
Secondary outcomes (5)
Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations
Measured: Within 1 year following hospital discharge
Influenza and pneumococcal vaccination status
Measured: Within 1 year following hospital discharge
Evolution of renal function
Note: assessed by creatinine levels and GFR by CKD EPI
Measured: During hospitalization for up to 2 months and within 1 year after discharge.
All-cause Rehospitalization
Assessed by: Rehospitalization for any cause other than hear failure after discharge.
Measured: Within 1 year following hospital discharge
All-cause mortality
Measured: Within 1 year following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Mar 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pr. Nicolas GIRERD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, Study chair, CHRU de NancyOlivier HUTTIN, Principal investigator, CHRU de NancyLaura FILIPPETTI, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338878
- Sponsor's protocol ID
- 2023PI087
- Acronym
- PATHWAY-HF
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Apr 2024
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes
- ClinicalTrials.gov ID
- NCT06338878
- Acronym / sponsor ID
- PATHWAY-HF / 2023PI087
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 1 Apr 2024 (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.
This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for cardiac decompensation in the cardiology department of CHRU of Nancy,
Key inclusion criteria (2 listed)
- Man or women ≥ 18 years
- Patients hospitalized for cardiac decompensation (ESC 2016 and 2021 criteria)
Key exclusion criteria (5 listed)
- Patient expressing refusal to participate in research
- Patient who is a minor or under administrative protection
- Pregnant women
- Patient with ventricular assistance
- Patient with congenital heart disease
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
All-cause post-hospitalization mortality
Time frame: Within 1 year following hospital discharge
Composite endpoint of all-cause post-hospitalization mortality and rehospitalization for heart failure with outcome 2
Rehospitalization for heart failure
Time frame: Within 1 year following hospital discharge
Composite endpoint of all-cause post-hospitalization mortality and rehospitalization for heart failure with outcome 1
5 secondary outcomes
Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations
Time frame: Within 1 year following hospital discharge
Influenza and pneumococcal vaccination status
Time frame: Within 1 year following hospital discharge
Evolution of renal function
Time frame: During hospitalization for up to 2 months and within 1 year after discharge.
All-cause Rehospitalization
Time frame: Within 1 year following hospital discharge
All-cause mortality
Time frame: Within 1 year following hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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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.
Nicolas GIRERD study chair
CHRU de Nancy
Olivier HUTTIN principal investigator
CHRU de Nancy
Laura FILIPPETTI principal investigator
CHRU de Nancy
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 Pr. Nicolas GIRERD 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 5 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: looking for participants now, as of the sponsor's last update on 1 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura FILIPPETI (0383157322 ext. +33, l.filippetti@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause post-hospitalization mortality (time frame: Within 1 year following hospital discharge). The study lists 2 primary outcomes in all. 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 1 Apr 2024.