Heart FailureNCT07150754
Cardiological Drug Classes And Falls in Older Adults
An observational study of Heart Failure and Fall, run by University Hospital, Caen at 1 site in France.
Trial summary
Heat failure is a fast gowing health issue with a rising incidence in older adults. Recommendations have recently been published to treat heart failure, but most clinical trials leading to these recommendations tended to exclude older adults. Older adults are at higher risk of falls and severe consequences of falls. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Fall
- What is being tested?
- Heart failure pharmacological treatments
- How many people
- 100,000 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2024to 1 Jul 2025
- 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 65 years and older
- All sexes
- Older adult
Study population: Patients aged 65 years and over who presented fall with one or more recommended heart failure drugs
Who may be able to join
- Age 65 years of older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital, Department of Pharmacology
Caen, Normandy, 14000
About this study
Official title: Heart Failure Pharmacological Treatments and Falls in Older Adults: A Disproportionality Analysis of the WHO Pharmacovigilance Database
Heat failure is a fast gowing health issue with a rising incidence in older adults. Recommendations have recently been published to treat heart failure, but most clinical trials leading to these recommendations tended to exclude older adults.
Older adults are at higher risk of falls and severe consequences of falls. All heart failure treatments are at risk of causing a fall through different mechanisms.
Read more
Based on the World Health Organization global database, the main objective of this study is to investigate the association between heart failure pharmacological treatments and the report of a fall in the database.
A disproportionality analysis will be performed. It will aim to assess whether some classes of heart failure drugs, and within these classes some individual drugs, are associated with a report of a fall.
A sensibilty analysis will also be performed. It will aim to examine the association between takien a heart failure pharmacological treatment, with a heat failure indication and/or a loop diuretic, and the report of a fall.
- Conditions
- Heart Failure, Fall
- Being tested
- Heart failure pharmacological treatments
- Keywords
- Heart failure, Falls, Pharmacological treatments
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart failure pharmacological treatmentsDrug
Identify a positive signal for fall with one or more of the recommended pharmacological treatments for heart failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Report of a fall with a recommended pharmacological treatment for heart failure
Measured: 02/11/2024
Secondary outcomes (1)
Sensibility analysis
Reports of falls with one or more of the respective drug classes that also had either "furosemide" prescription and/or "heart failure" as indication
Measured: 02/11/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start2 Nov 2024
- Primary completion1 Apr 2025
- Study completion1 Jul 2025
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, CaenThe 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
- Retrospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150754
- Sponsor's protocol ID
- PHARMACOGERIA092025
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Pharmacological Treatments and Falls in Older Adults: A Disproportionality Analysis of the WHO Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT07150754
- Acronym / sponsor ID
- PHARMACOGERIA092025
- Conditions
- Heart Failure, Fall
- Keywords
- Heart failure, Falls, Pharmacological treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 2 Sep 2025 (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.
Heat failure is a fast gowing health issue with a rising incidence in older adults. Recommendations have recently been published to treat heart failure, but most clinical trials leading to these recommendations tended to exclude older adults.
Older adults are at higher risk of falls and severe consequences of falls. All heart failure treatments are at risk of causing a fall through different mechanisms.
Based on the World Health Organization global database, the main objective of this study is to investigate the association between heart failure pharmacological treatments and the report of a fall in the database.
A disproportionality analysis will be performed. It will aim to assess whether some classes of heart failure drugs, and within these classes some individual drugs, are associated with a report of a fall.
A sensibilty analysis will also be performed. It will aim to examine the association between takien a heart failure pharmacological treatment, with a heat failure indication and/or a loop diuretic, and the report of a fall.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients aged 65 years and over who presented fall with one or more recommended heart failure drugs
Key inclusion criteria (1 listed)
- Age 65 years of older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart failure pharmacological treatmentsIdentify a positive signal for fall with one or more of the recommended pharmacological treatments for heart failure | Drug | – |
Primary outcome
Report of a fall with a recommended pharmacological treatment for heart failure
Time frame: 02/11/2024
1 secondary outcome
Sensibility analysis
Time frame: 02/11/2024
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 2 Sep 2025.
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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 and Fall, run by University Hospital, Caen 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 2 Sep 2025. 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?
Report of a fall with a recommended pharmacological treatment for heart failure (time frame: 02/11/2024). 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 2 Sep 2025.