The Spanish Familial Hypercholesterolaemia Cohort Study

ConditionFamilial Hypercholesterolaemia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age15+

SponsorFundación Hipercolesterolemia Familiar

About this trial

SAFEHEART is a large, on-going registry study in molecularly defined patients with heterozygous FH treated in Spain.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Index cases with genetic diagnosis of FH and their relatives over 15 years old with a genetic diagnosis of FH and their first-degree relatives

Disqualifiers

Patient unwillingness

Trial population

Index cases with genetic diagnosis of FH and their relatives over 15 years old with a genetic diagnosis of FH and their unaffected relatives

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,141 Participants

are grouped into 2 trial groups

Group A: Familial hypercholesterolaemia patients

Group B: Unaffected relatives

Trial outcomes

Primary outcomes

Prognostic assessment: time to fatal or non-fatal cardiovascular event.

Time to first cardiovascular event: fatal or non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, coronary revascularization, peripheral artery revascularization, aortic valve replacement or cardiovascular death.

Time frame

up to 12 years

Secondary outcomes

LDL-cholesterol level (mg/dl) at entry and at follow-up

LDL-cholesterol measurement at enrolment and after follow-up. At enrolment, a central core lab is in charge of the analysis. During follow-up, a yearly-based phone call is used to contact every subject and a complete lipid profile is obtained from the patient (obtained in his/her usual medical care).

Time frame

up to12 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Hipercolesterolemia Familiar

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III