Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

December 30, 2015 updated by: prof. dr. Werner Budts, Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent congenital heart defect closure before the age of 18 years and who are lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: From date of birth until date of study inclusion (up to 100 months)
From date of birth until date of study inclusion (up to 100 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Werner Budts, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56867

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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