Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Atrial Septal Defects Ventricular Septal Defects

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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No intervention was applied, because it is an observational study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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prof. dr. Werner Budts

Prof. dr. Werner Budts

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Werner Budts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZLeuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S56867

Identifier Type: -

Identifier Source: org_study_id