Management of Heart Failure in Italian Outpatients Clinics: Observational Study

NCT06287164 | Recruiting DMC

• 1 other identifier: 101
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Data collection OTHER

Data collection on heart failure therapy and follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HF patients in stable clinical conditions

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University of Naples, Department of Advanced Biomedical Sciences

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 29, 2024
• Study Start: March 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)