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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06287164
Other study ID # 101
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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