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NCT Number: NCT06445231

Echocardiography in Nursing Home

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.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases Heart Failure Heart Valve Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.

Thirty nursing homes and 1050 residents will be included overall

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Implementation of echocardiography in nursing homes

Diagnostic Test

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.

Primary outcomes

  1. Count of resident presenting a heart failure decompensation

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    A binary outcome will be constructed, based on the following algorithm: clinically significative change set to "yes" if a change in ongoing drug prescription is observed, and/or a cardiologist visit is planned, and/or a geriatrist visit is planned, and/or an hospitalization for clinical work-up is set, and/or a resume of the ultrasound is sent to the GP. Otherwise (all components set to "absent"), this outcome will be set to "None".

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Sophie BOUREAU, PH

CONTACT

[email protected]

33 2 40 16 85 35

Thierry LE TOURNEAU, PU-PH

CONTACT

[email protected]

33 2 40 16 54 98

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Directorate of Health Care Supply

Registry information

Official study title

Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER

Acronym: ECHOGER

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Jun 6, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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