Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445231
Other study ID # RC22_0449
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date September 1, 2029

Study information

Verified date May 2024
Source Nantes University Hospital
Contact Thierry LE TOURNEAU, PU-PH
Phone 33 2 40 16 54 98
Email thierry.letourneau@chu-nantes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1050
Est. completion date September 1, 2029
Est. primary completion date September 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 diseaseā€¦) - recent contagious disease such Covid (<15 days) - no consent to participate - no social security number

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Implementation of echocardiography in nursing homes
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Nantes University Hospital Directorate of Health Care Supply

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Presence of a clinically significative change in medical management and care in the month following ultrasound 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". 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy