Skip to main content
Clinical Trials/NL-OMON27057
NL-OMON27057
Recruiting
Not Applicable

Evaluation of a tailored approach towards informing family members at risk of inherited cardiac diseases: a randomized clinical trial

Academic Medical Center, University Medical Center Groningen & University Medical Center Utrecht0 sites425 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Predictive genetic testing, inherited cardiac diseases, inform family members at risk, tailored
Sponsor
Academic Medical Center, University Medical Center Groningen & University Medical Center Utrecht
Enrollment
425
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Academic Medical Center, University Medical Center Groningen & University Medical Center Utrecht

Eligibility Criteria

Inclusion Criteria

  • The study population consists of:
  • (1\) Index patients with an inherited cardiac disease and a putative pathogenic mutation (i.e., class 4 or 5 mutation): (a) Index patients who are the first in their family to attend pre\-test genetic counselling about genetic testing for inherited cardiac diseases, (b) Index patients that have at least one alive adult family member at risk of inheriting the mutation, (c) Index patients who are aged 18 years or older, (d) Index patients who are able to read and write Dutch. For final enrolment: Index patients who have a putative pathogenic mutation detected at the DNA test.
  • (2\) Their first\-degree, and second\-degree family members in case of a deceased connecting first\-degree family member that is affected or suspected to be affected (in case of sudden cardiac death), who are supposed to have a 50% risk of inheriting the disease\-causing mutation. (a) Family members who are aged 18 years and older, (b) Family members who are able to read and write Dutch.

Exclusion Criteria

  • (1\) Index patients and family members who have cognitive functioning problems and therefore are not able to provide informed consent.

Outcomes

Primary Outcomes

Not specified

Similar Trials