Cardiological Drug Classes And Falls in Older Adults

August 25, 2025 updated by: University Hospital, Caen

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14000
        • Caen University Hospital, Department of Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients aged 65 years and over who presented fall with one or more recommended heart failure drugs

Description

Inclusion Criteria:

  • Age 65 years of older

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Report of a fall with a recommended pharmacological treatment for heart failure
Time Frame: 02/11/2024
02/11/2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility analysis
Time Frame: 02/11/2024
Reports of falls with one or more of the respective drug classes that also had either "furosemide" prescription and/or "heart failure" as indication
02/11/2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2024

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

August 25, 2025

First Posted (Actual)

September 2, 2025

Study Record Updates

Last Update Posted (Actual)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHARMACOGERIA092025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Heart failure pharmacological treatments

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe