Cardiological Drug Classes And Falls in Older Adults
Heart Failure Pharmacological Treatments and Falls in Older Adults: A Disproportionality Analysis of the WHO Pharmacovigilance Database
1 other identifier
observational
100,000
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 2, 2025
CompletedSeptember 2, 2025
August 1, 2025
5 months
August 25, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Report of a fall with a recommended pharmacological treatment for heart failure
02/11/2024
Secondary Outcomes (1)
Sensibility analysis
02/11/2024
Interventions
Identify a positive signal for fall with one or more of the recommended pharmacological treatments for heart failure
Eligibility Criteria
Patients aged 65 years and over who presented fall with one or more recommended heart failure drugs
You may qualify if:
- Age 65 years of older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen University Hospital, Department of Pharmacology
Caen, Normandy, 14000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2025
First Posted
September 2, 2025
Study Start
November 2, 2024
Primary Completion
April 1, 2025
Study Completion
July 1, 2025
Last Updated
September 2, 2025
Record last verified: 2025-08