Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02691689

Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-29

21

Participants Needed

1

Research Sites

587 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Previous diagnosis of secundum atrial septal defect (ASD) or ventricular septal defect (VSD), with or without repair
  • Development of pulmonary arterial hypertension (PAH) defined as mean pulmonary artery pressure 65 mmHg by right heart catheterization, with pulmonary wedge pressure 64 15 mmHg and pulmonary vascular resistance > 3 Wood units
  • Preferably, families with congenital shunt lesions including at least three family members affected with ASD or VSD
Not Eligible

You will not qualify if you...

  • Other congenital heart disease
  • Mental retardation
  • Dysmorphic characteristics
  • Chronic lung disease or total lung capacity < 80% of predicted value
  • History of pulmonary embolism

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

W

Werner Budts, MD, PhD

CONTACT

C

Charlien Gabriels, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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