Clinical trials: Familial Hypercholesterolemias
Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B
Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact…
- Conditions
- Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation, Familial Hypercholesterolemia - Heterozygous
- Trial name
- ACCURATE (NCT05218005)
- Testing
- Research-based genetic test for Familial Hypercholesterolemia
- Where
- 2 sites in Canada
- Volunteers
- 140 people
- Sponsor
- University of British Columbia
Long QT Syndrome, Familial Hypercholesterolemia
Comparing Direct vs Indirect Methods for Cascade Screening
An important aspect of successful genomic medicine implementation is developing effective approaches for screening at-risk family members after probands are identified, also known as cascade screening.
- Conditions
- Long QT Syndrome, Familial Hypercholesterolemia, Ethics, Genetic Testing
- Trial name
- NCT05348564
- Testing
- Direct contact of family members for cascade screening of relevant variants
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Maryland, Baltimore
Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
Pediatric Reporting of Adult-Onset Genomic Results
The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among MyCode adolescent participants and their parents, and health behaviors of children who received…
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, Familial Hypercholesterolemia
- Trial name
- NCT03832985
- Testing
- Child(ren) receive an adult-onset result, Child(ren) received a pediatric-onset result, Control - Negative Result
- Where
- United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia
Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease
LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy.
- Conditions
- Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia
- Trial name
- NCT06112327
- Where
- 3 sites in New Zealand, United Kingdom
- Volunteers
- 116 people
- Sponsor
- Verve Therapeutics, Inc.
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
- Trial name
- NCT07421297
- Testing
- SYH2053 injection
- Where
- 2 sites in China
- Volunteers
- 760 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Homozygous Familial Hypercholesterolemia
The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
This repository will establish for the first time a system to carefully assess and monitor over time the general health and the amount of cholesterol in the arteries of U.S.
- Trial name
- NCT01109368
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The Rogosin Institute
Familial Hypercholesterolemias, Atherosclerotic Cardiovascular Disease (ASCVD)
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in…
- Trial name
- ATHERO-FH (NCT06960902)
- Testing
- Coronary CT scan with CAC score measurement
- Where
- 9 sites in France
- Volunteers
- 600 people
- Sponsor
- Nantes University Hospital
Heterozygous Familial Hypercholesterolemia
Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy
This study is an open-label, single ascending dose (SAD) study designed to evaluate the safety and tolerability of ART002g1 in patients with heterozygous familial hypercholesterolemia (HeFH) who require further reduction in…
- Trial name
- NCT07353398
- Testing
- ART002g1 Injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Familial Hypercholesterolemia
EAS Familial Hypercholesterolaemia Studies Collaboration
Familial hypercholesterolaemia (FH) is a common genetic disorder resulting in marked elevations in low-density lipoprotein cholesterol (LDL-C).
- Trial name
- FHSC (NCT04272697)
- Where
- United Kingdom
- Volunteers
- 75,000 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Heterozygous Familial Hypercholesterolemia (HeFH)
QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable lipid-lowering therapy.
- Trial name
- NCT07450378
- Testing
- QLC7401 Injection
- Volunteers
- 120 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia.
- Trial name
- NCT05952869
- Testing
- Enlicitide Decanoate
- Where
- 59 sites in United States, Australia and 15 more
- Volunteers
- 303 people
- Sponsor
- Merck Sharp & Dohme LLC
Familial Hypercholesterolemia
Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.
Familial hypercholesterolemia is the most common inherited disease of the lipid metabolism, however it remains underdiagnosed. Only 15 % of 30.000 possible patients have been found in Denmark.
- Trial name
- FIND (NCT05614219)
- Testing
- Biochemistry interpretive comment on elevated LDL-C levels
- Where
- 2 sites in Denmark
- Volunteers
- 2,000 people
- Sponsor
- Odense University Hospital
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
This observational, multicenter, retrospective and prospective study aims to evaluate the effect of lomitapide treatment on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia…
- Conditions
- Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE), Dyslipidemia
- Trial name
- LILITH (NCT06832371)
- Where
- 30 sites in France, Greece and 3 more
- Volunteers
- 73 people
- Sponsor
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
- Trial name
- NCT07421284
- Where
- China
- Volunteers
- 900 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Hypercholesterolemia, Familial
Screening for Familial Hypercholesterolemia in Children
Familial hypercholesterolemia is the most common treatable genetic disorder for which a simple, effective treatment is available, with few side effects.
- Trial name
- HYPERCHOF (NCT06555120)
- Testing
- blood sample
- Where
- France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Familial Hypercholesterolemia
Penn Family Screening for Familial Hypercholesterolemia
The goal of this clinical trial is to test two implementation strategies (automated health system [Penn Medicine]-mediated strategy vs.
- Trial name
- NHLBI-R33 (NCT05750667)
- Testing
- Cascade screening
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- Northwestern University
Familial Hypercholesterolemia
Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia
The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH) compared to women without FH.
- Trial name
- FH-FEMINA (NCT05367310)
- Where
- 4 sites in Czechia, Netherlands and 1 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
- Trial name
- ORION-13 (NCT04659863)
- Testing
- Inclisiran
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia
Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia
The main objective of this pilot study is to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of…
- Trial name
- DICA-HF (NCT05695937)
- Testing
- phytosterol, krill oil
- Where
- 9 sites in Brazil
- Volunteers
- 58 people
- Sponsor
- Hospital do Coracao