Prospective, Monocentric Pilot Study for the Identification of Known or Novel Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality. Next to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Previous diagnosis of secundum atrial septal defect (ASD) or ventricular septal defect (VSD), with or without repair

• Development of PAH, defined as mean PAP ≥ 25 mmHg by right heart catheterization, in combination with a pulmonary wedge pressure of ≤ 15 mmHg and a PVR (pulmonary vascular resistance) of \> 3 Wood units

• Preferably, families with congenital shunt lesions (at least three family members affected with ASD or VSD) will be considered for inclusion

Locations
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Contact Information
Primary
Werner Budts, MD, PhD
werner.budts@uzleuven.be
+32 16 344369
Backup
Charlien Gabriels, MD
charlien.gabriels@uzleuven.be
+32 16 341486
Time Frame
Start Date: 2015-11
Estimated Completion Date: 2026-02
Participants
Target number of participants: 21
Treatments
Other: Patients with ASD or VSD and PAH
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov