Management of Heart Failure in Italian Outpatients Clinics: Observational Study

Heart Failure Clinical Trial

— OPTIMA-HF  

Official title:

Optimization of Therapy in the Italian Management of Heart Failure: OPTIMA-HF Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287164
• Other study ID #: 101
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.

Aim of the Optimization of Therapy in the Italian Management of Heart Failure [OpTIMa-HF] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: age >18 years, post-menopausal, permanent sterile, or childbearing potential on highly effective contraceptive methods women, stable clinical conditions (NYHA class I-III), outpatients setting, capability to understand the study procedures and sign the informed consent form.

Exclusion Criteria: any clinical condition that would have jeopardized patient safety while participating in this study.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Data collection
Data collection on heart failure therapy and follow up

Locations

Country	Name	City	State
Italy	Federico II University of Naples, Department of Advanced Biomedical Sciences	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HF treatment adherence according to the most recent European Guidelines	Outpatients clinic treatment adherence will be measured as the percentage of patients receiving guideline-directed medical therapy prescriptions.	12 months