PMMHRI - Familial Hypercholesterolemia Registry

NCT06571630 | Recruiting

• 1 other identifier: PMMHRI-FH-Registry
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Familial Hypercholesterolemia

Keywords

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Therapeutic goals achivement

  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.

  5 years

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients diagnosed with FH, including both children and adults,

You may qualify if:

• FH diagnosis

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland

Lodz, 93-338, Poland

RECRUITING

Related Publications (3)

• Lewek J, Konopka A, Starostecka E, Penson PE, Maciejewski M, Banach M. Clinical Features of Familial Hypercholesterolemia in Children and Adults in EAS-FHSC Regional Center for Rare Diseases in Poland. J Clin Med. 2021 Sep 22;10(19):4302. doi: 10.3390/jcm10194302.

  PMID: 34640319 BACKGROUND

• European Atherosclerosis Society Familial Hypercholesterolaemia Studies Collaboration. Familial hypercholesterolaemia in children and adolescents from 48 countries: a cross-sectional study. Lancet. 2024 Jan 6;403(10421):55-66. doi: 10.1016/S0140-6736(23)01842-1. Epub 2023 Dec 12.

  PMID: 38101429 BACKGROUND

• EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC). Global perspective of familial hypercholesterolaemia: a cross-sectional study from the EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC). Lancet. 2021 Nov 6;398(10312):1713-1725. doi: 10.1016/S0140-6736(21)01122-3. Epub 2021 Sep 7.

  PMID: 34506743 BACKGROUND

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA

CONTACT

+48 42 2711124; maciej.banach@icloud.com

Joanna Lewek, MD, PhD

CONTACT

+48 42 2711593; joanna.lewek@iczmp.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 26, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

PL (1)