NCT07150754

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Heart failureFallsPharmacological treatments

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

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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

Locations