Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

Atrial Septal Defects Clinical Trial

Official title:

Prospective, Monocentric Study for the Evaluation of Latent Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions Lost to Follow-up.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552485
• Other study ID #: S56867
• Status: Completed
• Phase: N/A
• First received: September 10, 2015
• Last updated: December 30, 2015
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Description:

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR). This causes pressure overload in the right heart, and thereby right ventricular (RV) and right atrial (RA) dysfunction, which may implicate considerable morbidity and even mortality. Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced (partially irreversible) stage and treatment is often initiated too late.

Dismissal from follow-up after a surgical correction of simple CHD was customized in the seventies and eighties. There is no literature available that learns us whether these patients really need follow-up or not. A substantial number must have insidiously developed PAH or mild pulmonary vascular disease (PVD) and still are prone to develop PAH later in life. It is relevant to recall these patients dismissed from follow-up in the past, because they might carry a lot of useful information on the natural history of PAH development. Focus will lie mainly on patients with simple shunt lesions, as atrial septal defect (ASD) and ventricular septal defect (VSD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous repair for secundum ASD, VSD

Exclusion Criteria:

• Other congenital heart disease

• Chronic lung disease or total lung capacity < 80% of predicted value

• History of pulmonary embolism

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Septal Defects
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Heart Septal Defects, Ventricular
• Hypertension
• Ventricular Septal Defects

Intervention

Other:
• No intervention was applied, because it is an observational study

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		From date of birth until date of study inclusion (up to 100 months)	No