NCT Number: NCT06571630
The registry is maintained at the Regional Centre for Rare Diseases, established in 2016, within Polish Mother's Memorial Hospital Research Institute. This facility diagnoses and treats over 80 distinct rare diseases in patients from across the country, including those with phenotypically or genetically confirmed familial hypercholesterolemia (FH).
Interested in participating?
Request Info1 day and older
All sexes
Observational
Lodz, 93-338, Poland
Location status: Recruiting
Joanna Lewek, MD, PhD
CONTACT
Joanna Lewek, MD, PhD
SUB_INVESTIGATOR
Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA
CONTACT
Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA
PRINCIPAL_INVESTIGATOR
All consecutive patients diagnosed with FH, including both children and adults, are being enrolled from December 2018 to May 2024. Each patient receives a consultation with a clinical geneticist and a dietitian, who provide recommendations for cascade screening among family members and promote a healthy and balanced diet. The study includes all index cases, with children also serving as index cases.
The PMMHRI FH registry is managed by physicians from the RCRD, who exclusively make all diagnostic and treatment decisions. The purpose of the registry is to investigate the clinical characteristics, diagnosis, management, achievement of therapeutic goals, and outcomes of FH patients. Inclusion criteria are based on phenotypic or genetic diagnosis of FH. Phenotypic diagnosis is conducted using the Dutch Lipid Clinic Network criteria for adults, and the Simon Broome criteria for children. During the baseline visit, comprehensive data collection includes all available lipidogram results, aiming to obtain naive LDL-C values, highest values, and treated values. All data collected during the enrollment period are included in the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Time frame: 5 years
For each patient, we collect data on the levels of all lipid profile fractions: such as total cholesterol [mg/dl], low density lipoprotein cholesterol - LDL [mg/dl], high density lipoprotein cholesterol HDL [mg/dl], triglycerides [mg/dl], non-HDL [mg/dl] and lipoprotein(a) during both dual and triple therapy. Additionally, we will assess the achievement of the therapeutic target as defined by the ESC guidelines. The therapeutic target for each patient will be evaluated individually based on their risk, in accordance with the ESC guidelines.
Contact information is provided by the study sponsor or research team.
Joanna Lewek, MD, PhD
CONTACT
Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA
CONTACT
Polish Mother Memorial Hospital Research Institute
Other
Polish Mother's Memorial Hospital Research Institute - Familial Hypercholesterolemia Registry
Acronym: FH-Registry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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