CClinicalTrials.gg
Status unknownNCT01783405Updated Jun 10, 2014

Cardiovascular Disease in FH Heterozygous

An observational study in Familial Hypercholesterolemia, sponsored by Sociedad Española de Arteriosclerosis. Status unknown at 3 sites in Spain. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-06-10.

Sponsored by Sociedad Española de Arteriosclerosis · Observational

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,100
Ages
30 Years to 70 Years
Sex
All
01

Study 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

Read the detailed description

Familial hypercholesterolemia (FH) is the most common autosomal dominant disease in most countries, including Spain. Its prevalence is estimated at one in every 350-500 people being higher in certain areas with certain genetic isolation as French Canadians, Christian Lebanese, or "Afrikaners" in South Africa. The HF is characterized by a very high concentration of LDL cholesterol, familial autosomal dominant pattern, tendon xanthomas and increased risk of premature coronary disease. Without drug treatment, approximately 50% of men before age 50 years and the same percentage in women before age 60 will suffer a serious manifestation of cardiovascular disease. It has been estimated that HF limits life expectancy about 20 years for males and about 12 years for women, so that effective treatment is a priority in cardiovascular prevention. Most cases of HF are caused by mutations in the gene encoding the receptor of LDL particles (LDLR). More than 1000 different mutations in the LDLR gene (LDLR) have been described as the cause of HF, many of them specific to a territory or population group. In Spain we have described 235 different mutations and is one of the best studied populations in the world from the genetic point of view. This is because in Spain we have an efficient tool for genetic diagnosis of HF, referred Lipochip ® (Progenika Biopharma, Derio, Vizcaya), and allows us to be pioneers in the world in the diagnosis and treatment of HF.

Most cases of HF in Spain, and especially the cases with a genetic diagnosis, which represents the true diagnosis, are controlled by the Lipid Unit network of the Spanish Atherosclerosis Society (SEA) distributed throughout the national territory, and in many cases using homogeneous clinical criteria for the clinical management of these patients. For the above reasons the SEA is the ideal setting for studies in a wide range of subjects with HF, especially those requiring an accurate diagnosis. The advent of statins has been a landmark for people suffering from HF. Since the late 80s of last century we have this class of drugs. They have reduced and almost normalized LDL concentrations in FH and have substantively altered the natural progression of the disease. However, the health impact brought about by the statins in HF is unknown. Indirect data from the UK Simon Broome Register suggest that subjects with HF now have a better prognosis than 20 years ago but that register has many limitations that make difficult to know the real impact of the treatment.

Retrospective, obervacional, multicenter, based on Lipid Units of the Sociedad Española de Arteriosclerosis.

Our hypothesis is that statins have improved cardiovascular prognosis in recent years in heterozygous FH subjects. 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.

To establish the current prevalence of cardiovascular disease in adult subjects suffering from genetically diagnosed HF

To know the impact that drug treatment has resulted in cardiovascular disease when compared with that of their affected parents with a longer period of exposure to hypercholesterolemia.

02

Conditions studied

  • Familial Hypercholesterolemia

Keywords

  • LDLR mutation
  • Statin
  • Cardiovascular disease
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 573 across 1,483 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

This is the only study on the registry with Sociedad Española de Arteriosclerosis as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heterozygous FH from the Lipid Units of the Sociedad Española de Arteriosclerosis (Spanish Atherosclerosis Society)

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Same gender afected brothers of probands
  • Homozygous FH
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    FH heterozygous

  • Controls

    Parents of FH heterozygotes with FH

06

What researchers measure

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

    Time frame: Baseline

Secondary outcomes

  1. Age first stroke

    Time frame: Baseline

  2. Age first coronary event

    Time frame: Baseline

  3. Age first peripheral vascular disease

    Time frame: Baseline

  4. Age diagnosis aortic aneurysm

    Time frame: Baseline

07

Study locations

3 of 3 sites recruiting
  • Hospital San Jorge
    Huesca, Spain
    • Jose Puzo, MD, PhD · Contact
    Recruiting
  • Hospital Universitario Miguel Servet
    Zaragoza, 50009, Spain
    • Fernando Civeira, MD, PhD · Contact · civeira@unizar.es · 34 976765500
    • Sofia Perez-Calahorra · Sub investigator
    • Rocio Mateo-Gallego · Sub investigator
    • Estibaliz Jarauta, MD · Sub investigator
    • Ana Cenarro, PhD · Sub investigator
    Recruiting
  • Hospital Royo Villanova
    Zaragoza, Spain
    • Juan Ferrando, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01783405
Lead sponsor
Sociedad Española de Arteriosclerosis
Collaborators
Hospital Miguel Servet, Universidad de Zaragoza
Responsible party
Sponsor
First posted
Feb 4, 2013
Start date
Feb 2013
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Jun 10, 2014

Study contacts

Fernando Civeira, MD, PhD
Contact
civeira@unizar.es
34976765500 ext. 2884
Fernando Civeira, MD, PhD
principal investigator · Universidad de Zaragoza

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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