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Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

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ClinicalTrials.gov Identifier: NCT02552485
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
prof. dr. Werner Budts, Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment
Atrial Septal Defects Ventricular Septal Defects Other: No intervention was applied, because it is an observational study

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).


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Study Type : Observational
Actual Enrollment : 93 participants
Time Perspective: Prospective
Official Title: Prospective, Monocentric Study for the Evaluation of Latent Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions Lost to Follow-up.
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015





Primary Outcome Measures :
  1. Mortality [ Time Frame: From date of birth until date of study inclusion (up to 100 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552485


Locations
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Belgium
UZLeuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Werner Budts, MD, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: prof. dr. Werner Budts, Prof. dr. Werner Budts, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02552485     History of Changes
Other Study ID Numbers: S56867
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Hypertension
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Septal Defects, Atrial
Vascular Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities