Optimization of Therapy in the Italian Management of Heart Failure: OPTIMA-HF Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- HF treatment adherence according to the most recent European Guidelines
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
HF treatment adherence according to the most recent European Guidelines
Time Frame: 12 months
Outpatients clinic treatment adherence will be measured as the percentage of patients receiving guideline-directed medical therapy prescriptions.
Secondary Outcomes
No secondary outcomes reported
Investigators
Pasquale Perrone Filardi
Professor
Federico II University