Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571630
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
PMMHRI - Familial Hypercholesterolemia Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Polish Mothers Memorial Hospital Research Institute - Familial Hypercholesterolemia Registry
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FH-Registry
Brief Summary:
The registry is maintained at the Regional Centre for Rare Diseases established in 2016 within Polish Mothers 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None