Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

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Brief Title

Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

Official Title

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

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.
    

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


Primary Outcome

Mortality


Condition

Atrial Septal Defects

Intervention

No intervention was applied, because it is an observational study


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

93

Start Date

January 2015

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Werner Budts, MD, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT02552485

Organization ID

S56867


Responsible Party

Principal Investigator

Study Sponsor

Universitaire Ziekenhuizen Leuven


Study Sponsor

Werner Budts, MD, PhD, Principal Investigator, Universitaire Ziekenhuizen Leuven


Verification Date

December 2015