Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04494464
Other study ID # Hypercholesterolemia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date May 2017

Study information

Verified date July 2020
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.


Description:

Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified from the hospital database. A questionnaire was completed via phone. Patients were classified as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid Clinical Network Criteria


Recruitment information / eligibility

Status Completed
Enrollment 367
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients older than 18 years old and have a serum LDL-C=250 mg/dL

Exclusion Criteria:

- Patients who refuse dto interview

- Serum TSH=10 mIU/mL

- Glomerulonephritis or nephrotic syndrome

- ALT or AST higher than 3 times of normal limits

- Serum triglyceride >400 mg/dL

Study Design


Intervention

Other:
No intervention


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment rates Patients with a serum LDL-C=250 mg/dL were identified from the database of our hospital. Dutch Lipid Clinical Network Criteria was used to classify patients as definite, probable and possible FH. Patients were reached by phone and a questionnaire was applied. The questionnaire consisted of questions related with clinical and physical examination findings defined in theDutch Lipid Clinical Network Criteria. Total cholesterol, LDL-C, HDL-C, triglyceride levels were obtained from the medical records. Patients were asked whether they were using lipid lowering drugs. If they were not using, the cause of this was asked. By this way, we determined the rate of use of lipid lowering drugs in patients with LDL-C=250 mg/dL and have definite, probable or possible familial hypercholesterolemia January 2010 and December 2016
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05284513 - Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH) N/A
Enrolling by invitation NCT05271305 - Pilot Study for a National Screening for Familial Hypercholesterolemia
Completed NCT02750527 - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Not yet recruiting NCT00924339 - Soy Food Intervention Trial N/A
Withdrawn NCT00751608 - Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients Phase 2
Terminated NCT00079846 - Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy Phase 2
Completed NCT02624869 - Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) Phase 3
Recruiting NCT05758779 - The Danish Familial Hypercholesterolemia Organized Coronary Screening Trial N/A
Enrolling by invitation NCT04929457 - Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
Not yet recruiting NCT04455581 - A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia Phase 2
Recruiting NCT04101149 - Genetic Causes of Familial Hypercholesterolemia
Completed NCT00943306 - Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT02462655 - Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia N/A
Terminated NCT00079859 - Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Phase 2
Recruiting NCT05066932 - Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia
Not yet recruiting NCT04958629 - A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population
Completed NCT02709850 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia Phase 1
Active, not recruiting NCT03832985 - Pediatric Reporting of Adult-Onset Genomic Results Early Phase 1
Terminated NCT02013713 - French Observatory of Familial Hypercholesterolemia in Cardiology
Recruiting NCT02009345 - Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada