NCT06445231

Brief Summary

The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress32%
Oct 2024Jan 2030

First Submitted

Initial submission to the registry

May 14, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 2, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

May 14, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

EchocardiographyNursing HomeImplementationHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Count of resident presenting a heart failure decompensation

    Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure

    12 months

Secondary Outcomes (1)

  • Presence of a clinically significative change in medical management and care in the month following ultrasound

    12 months

Study Arms (2)

Echocardiographic screening arm

EXPERIMENTAL

Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion.

Diagnostic Test: Implementation of echocardiography in nursing homes

Usual care

NO INTERVENTION

Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual.

Interventions

An ultrasound will be carried out in the EHPAD, the result of which will be interpreted by a cardiologist then sent to the establishment and the attending physician with instructions to follow.

Echocardiographic screening arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Nursing homes residents with a life-expectancy estimated \> 1 year, and able to participate to the study, giving an oral consent

You may not qualify if:

  • no accessible to echocardiography
  • closed unit (severe Alzheimer disease…)
  • recent contagious disease such Covid (\<15 days)
  • no consent to participate
  • no social security number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Heart DiseasesHeart FailureHeart Valve Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Thierry LE TOURNEAU, PU-PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Not relevant
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

June 6, 2024

Study Start

October 2, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations