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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06360315
Other study ID # 202201265
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2, 2023
Est. completion date June 2024

Study information

Verified date April 2024
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12000
Est. completion date June 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion criteria: - Adult patients over 45 - Residing in the Occitanie region, France - With heart failure registered as ALD - Who have declared an attending physician - Who have not received a pneumococcal vaccination for more than 24 months (due to the length of time available in the database) Exclusion criteria: -None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Incentive letter for pneumococcal vaccination to the patient and to the GP
Incentive letter for pneumococcal vaccination to the patient and to the GP

Locations

Country Name City State
France Montpellier University Hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1-year Pneumococcus vaccination rate at 1-year
Secondary 1-year all-cause hospital admission rate at 1-year
Secondary 1-year specific hospital admission rate at 1-year
Secondary 1-year all-cause mortality rate at 1-year
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