Comparing health outcomes in patients with pulmonary atresia and different heart circulations
A Longterm Follow-up and Comparison of Morbidity and Heart Health Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation
This study is trying to see how different heart circulation types affect the health and quality of life in people aged 15 and older with pulmonary atresia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05928234 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the morbidity and health outcomes of patients with pulmonary atresia with intact ventricular septum (PA-IVS) who have either univentricular or biventricular circulation. Participants aged 15 years and older will be assessed for mortality, quality of life, comorbidity, cardiac function, and work capacity through questionnaires and various medical examinations, including echocardiograms and MRIs. The study seeks to determine if significant differences exist between the two groups regarding these health metrics.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 15 years or older who were born with pulmonary atresia with intact ventricular septum.
Not a fit: Patients younger than 15 years old at the start of the study will not benefit from this research.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the health outcomes of different circulatory patterns in patients with PA-IVS, potentially guiding treatment decisions.
How similar studies have performed: While this study addresses a specific comparison within a rare condition, similar observational studies have shown success in elucidating health outcomes in congenital heart defects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals born with pulmonary atresia with intact ventricular septum (PA-IVS) who are 15 years or older at the start of the study. * Regarding the mortality variable, research subjects who have died after the age of 15 years old will be included. Exclusion Criteria: Individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.
Where this trial is running
Gothenburg
- Pediatric Heart Center, Queen Silvia's Children's hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: stina manhem, MD
- Email: stina.manhem@vgregion.se
- Phone: +46735080342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.