Management of Heart Failure in Italian Outpatients Clinics: Observational Study

NCT ID: NCT06287164

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

Data collection on heart failure therapy and follow up

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Pasquale Perrone Filardi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federico II University of Naples, Department of Advanced Biomedical Sciences

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Pasquale Perrone Filardi, MD

Role: primary

Other Identifiers

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101

Identifier Type: -

Identifier Source: org_study_id