PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes

Heart Failure Clinical Trial

— PATHWAY-HF  

Official title:

PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338878
• Other study ID #: 2023PI087
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: January 2029

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Laura FILIPPETI
• Phone: 0383157322
• Email: l.filippetti[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2029
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Man or women = 18 years
• Patients hospitalized for cardiac decompensation (ESC 2016 and 2021 criteria)

Exclusion Criteria:

• Patient expressing refusal to participate in research
• Patient who is a minor or under administrative protection
• Pregnant women
• Patient with ventricular assistance
• Patient with congenital heart disease

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Pr. Nicolas GIRERD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause post-hospitalization mortality	Composite endpoint of all-cause post-hospitalization mortality and rehospitalization for heart failure with outcome 2	Within 1 year following hospital discharge
Primary	Rehospitalization for heart failure	Composite endpoint of all-cause post-hospitalization mortality and rehospitalization for heart failure with outcome 1	Within 1 year following hospital discharge
Secondary	Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations		Within 1 year following hospital discharge
Secondary	Influenza and pneumococcal vaccination status		Within 1 year following hospital discharge
Secondary	Evolution of renal function	Note: assessed by creatinine levels and GFR by CKD EPI	During hospitalization for up to 2 months and within 1 year after discharge.
Secondary	All-cause Rehospitalization	Assessed by: Rehospitalization for any cause other than hear failure after discharge.	Within 1 year following hospital discharge
Secondary	All-cause mortality		Within 1 year following hospital discharge