Cardiovascular Disease in FH Heterozygous
1 other identifier
observational
1,100
1 country
3
Brief Summary
The objective of this project is to establish the current prevalence of cardiovascular disease in adult subjects suffering from genetically diagnosed HF, and to know the impact that drug treatment has course in cardiovascular disease when compared with that of their affected parents with a much longer period of exposure to hypercholesterolemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 10, 2014
June 1, 2014
1.8 years
January 29, 2013
June 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Age first cardiovascular event
Age of first cardiovascular event is considered at the time of the last visit at the lipid clinic. Inclusion in the study has to be done within 6 moths from the last visit
Baseline
Secondary Outcomes (4)
Age first stroke
Baseline
Age first coronary event
Baseline
Age first peripheral vascular disease
Baseline
Age diagnosis aortic aneurysm
Baseline
Study Arms (2)
Cases
FH heterozygous
Controls
Parents of FH heterozygotes with FH
Eligibility Criteria
Heterozygous FH from the Lipid Units of the Sociedad Española de Arteriosclerosis (Spanish Atherosclerosis Society)
You may qualify if:
- Age ≥ 30 and ≤ 70
- cLDL ≥ 95th percentile
- Functional mutation in LDLR or APOB in the proband or first degreee relative
- At least 10 years on statin treatment
- Lipid values and cardiovascular status of both parents
You may not qualify if:
- Same gender afected brothers of probands
- Homozygous FH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sociedad Española de Arteriosclerosislead
- Hospital Miguel Servetcollaborator
- Universidad de Zaragozacollaborator
Study Sites (3)
Hospital San Jorge
Huesca, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Hospital Royo Villanova
Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Civeira, MD, PhD
Universidad de Zaragoza
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2013
First Posted
February 4, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 10, 2014
Record last verified: 2014-06