Prospective investigation of clinical, lipidological, vascular and hepatic parameters with regard to cardiovascular risk factors and primary prevention in childhood
Organizational Data
- DRKS-ID:
- DRKS00031182
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-02-06
- Last update in DRKS:
- 2023-02-06
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
The primary aim of this study is to examine the constellation of clinical, laboratory and imaging parameters in children with risk diseases with regard to their importance for primary prevention of subsequent cardiovascular diseases.
Health condition or problem studied
- Free text:
- • GH therapy in pituitary insufficiency ICD10 = E23.0 • Autoimmune thyroid disease under therapy E06.3 • Hypothyroidism under therapy E03.9, E03.1 • Pubertas tarda under therapy E30.0 • Precocious puberty during therapy E30.1, E25.8, E22.8 • Allergies J30.1, J30.3, T78.1 • Heterozygous familial hypercholesterolemia, dyslipidemias E78.0 – E78.9 • Hyperlipoprotein(a)emia E78.0 • Arterial hypertension I10.0 - I10.9 • Cardiac Vitium Q24.9 , I05 • Cardiomyopathy I42 • Kawasaki disease WITHOUT persistent aneurysm M30.3 • Cystic fibrosis E84 • Thalassemia D56 • Obese children and adolescents (E65 - E68) with a BMI > percentile 97 • Homozygous Familial Hypercholesterolemia E78.0 • Hyperlipoproteinemia type 3 E78.0 • Fatty liver disease K71, K74, K75, K76 • Lipodystrophy E88.1 • Type 1 diabetes mellitus E10 - E13 • Congenital cholestasis Q44 • Kawasaki disease WITH persistent aneurysm M30.3 • After stem cell transplantation Z94.8 • Graft versus host disease (GvHD) of the liver K77, T86, K94 • Leukemia C91, C92, C94, C95 • Medulloblastoma C71.6 • Ependymoma C71.9, C72 • Sarcoma C49.9 • Neuroblastoma C74.9, C72.2 • Nephroblastoma C64 • Hemosiderosis E83.1 • Immune compromise after chemotherapy D90
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Pediatric patients < 20 years old who are being treated for a disease and do not have an explicitly increased risk of dyslipidemia, cardiovascular and hepatic diseases.
- Arm 2:
- Pediatric patients < 20 years old who are being treated for a disease and have an increased risk of dyslipidemia, cardiovascular and hepatic diseases.
Endpoints
- Primary outcome:
- The first expectation is that a preventive examination with identification of pathological lipid constellations in childhood allows for an improved early risk characterization with regard to cardiovascular complications. For this purpose, the analysis of the sdLDL cholesterol, the Lp(a) isoforms, apolipoprotein B, adiponectin and CK18F is included in this analysis.
- Secondary outcome:
- Our second expectation is that in different risk groups as well as in individual different diseases, characteristic findings of the outcomes will be available early and expect that these will differ in patients with type 1 diabetes mellitus, in familial hypercholesterolemia and in cancer survivors.
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinikum der Goethe Universität Frankfurt
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2023-01-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 300
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 0 Years
- Maximum Age:
- 20 Years
- Additional Inclusion Criteria:
- • Written consent to participate • Age at birth and < 20 years of age
Exclusion Criteria
• Age ≥ 20 years at the start of the study • Acute illness • other chronic diseases or infections (e.g. HIV, TB) • Pregnancy • Known alcohol, drug and/or medication abuse • Parental Inability to Informed Consensus
Addresses
Primary Sponsor
- Address:
- Goethe Universität, Klinikum60590 FrankfurtGermany
- Telephone:
- 069630180400
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- KKJM, Klinikum Goethe UniversitätUlrich PaetowTheodor-Stern-Kai, 760590 FrankfurtGermany
- Telephone:
- 069630180400
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- KKJM, Klinikum Goethe UniversitätUlrich PaetowTheodor-Stern-Kai, 760590 FrankfurtGermany
- Telephone:
- 069630180400
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- KKJM, Klinikum Goethe UniversitätUlrich PaetowTheodor-Stern-Kai, 760590 FrankfurtGermany
- Telephone:
- 069630180400
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Dr. Hans-Messer Stiftung65812 Bad SodenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-06-10
- Ethics committee number:
- 2022-827
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-09-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry