Evaluating plaque regression in young patients with familial hypercholesterolemia through aggressive lipid lowering therapy
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
This study is testing if strong cholesterol-lowering treatment can help young adults with familial hypercholesterolemia reduce plaque buildup in their arteries and improve their heart health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05783804 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the potential for significant plaque regression in young adults diagnosed with heterozygous familial hypercholesterolemia, specifically those aged 18 to 50 years. Participants will undergo early and intensive lipid lowering therapy to assess its effectiveness in reversing coronary artery disease progression. The study aims to determine if aggressive treatment can lead to improved cardiovascular outcomes in this high-risk population. The research will focus on measuring changes in plaque characteristics over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 with a diagnosis of heterozygous familial hypercholesterolemia and elevated LDL cholesterol levels.
Not a fit: Patients with renal insufficiency, a history of cardiovascular events, or other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies that significantly reduce cardiovascular risks in young patients with familial hypercholesterolemia.
How similar studies have performed: While this approach is focused on a specific demographic, similar studies have shown promise in lipid lowering therapies for cardiovascular disease, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with heterozygous familial hypercholesterolemia * Adult between 18 and 50 years old * LDL cholesterol levels above 100 mg/dl (\>2.6 mmol/L) at inclusion Exclusion Criteria: * Renal insufficiency, defined as eGFR \< 30 ml/min * History of atherosclerotic cardiovascular events * Atrial fibrillation * Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erik SG Stroes, MD, PhD — Amsterdam UMC, location AMC
- Study coordinator: Erik SG Stroes, MD, PhD
- Email: e.s.stroes@amsterdamumc.nl
- Phone: +205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.