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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Laura FILIPPETI; Phone Number: +33 0383157322; Email: l.filippetti@chru-nancy.fr
• Study Contact Backup: Name: Nicolas GIRERD; Phone Number: +33 0383157322; Email: n.girerd@chru-nancy.fr

Study Locations

• France
  • Nancy, France
    • Recruiting
    • CHRU de Nancy
    • Contact: Laura FILIPPETTI; Email: l.filippetti@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for cardiac decompensation in the cardiology department of CHRU of Nancy,

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations		Within 1 year following hospital discharge
Influenza and pneumococcal vaccination status		Within 1 year following hospital discharge
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.
All-cause Rehospitalization	Assessed by: Rehospitalization for any cause other than hear failure after discharge.	Within 1 year following hospital discharge
All-cause mortality		Within 1 year following hospital discharge

Collaborators and Investigators

• Sponsor: Pr. Nicolas GIRERD
• Investigators: Study Chair: Nicolas GIRERD, CHRU de Nancy; Principal Investigator: Olivier HUTTIN, CHRU de Nancy; Principal Investigator: Laura FILIPPETTI, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2023PI087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No