An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia

NCT07606118 | Not Yet Recruiting DMC

• 1 other identifier: TRAP-HC
• Study Type: observational
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

TRAP-HC is a multicenter, observational, longitudinal, prospective study designed to evaluate real-world treatment patterns and lipid-lowering therapy (LLT) management in patients with hypercholesterolemia, including familial hypercholesterolemia (FH), who are at high, very high, or extreme cardiovascular risk. Approximately 2,500 adult patients will be enrolled across up to 15 Italian LIPIGEN network centers and followed for 12 months as part of routine clinical practice. The study aims to assess LDL-C goal attainment according to current European guidelines, evaluate changes in lipid profiles over time, and investigate treatment adherence, persistence, and therapeutic modifications in response to clinical needs. Data collected during routine visits will include lipid parameters, cardiovascular history, concomitant therapies, safety outcomes, and patient-reported adherence measures. By providing real-world evidence on the management of hypercholesterolemia in high-risk populations, the study seeks to identify current gaps between guideline recommendations and clinical practice and to support optimization of cardiovascular risk reduction strategies.

Conditions

Hypercholesterolaemia; Familial Hypercholesterolaemia; CVD Risk

Keywords

LDL Cholesterol; Lipid-Lowering Therapy; Cardiovascular risk; LDL-C goal attainment; Real-world evidence; Lipid Profil; Adherence to Lipid-Lowering Therapies; Changes in Treatment Regimens; Patient Attitudes and Clinical Practices

Outcome Measures

Primary Outcomes (2)

• LDL-C Levels

  Distance from LDL-c goal according to EAS/ESC guidelines and the type of lipid lowering approach will be analyzed.

  Baseline, 6 months and 12 months

• Lipid Profile

  This includes total cholesterol, HDL-C, and triglycerides. A measure of cumulative lipid exposure such as "Cholesterol Years" will be determined whenever available. The aim is to evaluate the overall impact of lipid- lowering therapies (LLTs) on the lipid profile and cardiovascular risk reduction.

  Baseline, 6 months and 12 months

Secondary Outcomes (4)

• Adherence to Lipid-Lowering Therapies (LLTs)

  Baseline, 6 months and 12 months

• Changes in Treatment Regimens

  6 months and 12 months

• Patient Attitudes

  Baseline and 12 months

• Clinical Practices

  Baseline and 12 months

Study Arms (1)

Patients with hypercholesterolemia or patients at high, very high or extreme CVD risk

Adult patients (≥18 years) with hypercholesterolemia, including those diagnosed with familial hypercholesterolemia (clinical or genetic FH), or patients at high, very high or extreme CVD risk with a baseline visit during a six-month enrollment window.

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

Adult patients (≥18 years) with hypercholesterolemia, including those diagnosed with familial hypercholesterolemia (clinical or genetic FH), or patients at high, very high or extreme CVD risk with a baseline visit during a six-month enrollment window.

You may qualify if:

• Age ≥ 18 years
• Diagnosis of hypercholesterolemia (including clinical or genetic FH) OR high/very high/extreme CV risk
• Baseline visit within enrollment window (six months)

You may not qualify if:

• Significant secondary dyslipidemia (e.g. hypertriglyceridemia)
• Treatment changes due to non-hypercholesterolemia conditions

Sponsors & Collaborators

• CMV-Stat S.r.l.: collaborator
• Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi): lead

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05