Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

Related Clinical Trial
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects The Effect of Transcatheter VSD Closure on Children’s Appetite, Hormones and Growth The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters Improving Care for Children With Congenital Heart Disease. Lifetech MFO Post-Market Clinical Follow-Up Study Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics Optical Tissue Identification for Myocardial Architecture Measures to Lower the Stress Response in Pediatric Cardiac Surgery Cardiac Function After Transcatheter VSD Closure The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder – Post Approval Study The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects. Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol Optimal Timing for Repair of Left to Right Shunt Lesions Use of Ketamine Prior to Cardiopulmonary Bypass in Children Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect Longterm Outcome After Ventricular Septal Defect Closure Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER Hybrid Closure of Congenital Heart Disease

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


Primary Outcome



Atrial Septal Defects


No intervention was applied, because it is an observational study


* 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


Estimated Enrollment


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




18 Years - N/A

Accepts Healthy Volunteers



Werner Budts, MD, PhD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Universitaire Ziekenhuizen Leuven

Study Sponsor

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

Verification Date

December 2015