A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Atresia With Intact Ventricular Septum. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this observational study is to compare patients with pulmonary atresia with intact ventricular septum (PA-IVS) with univentricular circulation to patients with the same heart defect but that has a biventricular circulation in regards to mortality, quality of life, comorbidity, cardiac function, and work capacity. The main questions the study aims to answer are: • Do mortality, quality of life, comorbidity, cardiac function, and work capacity differ between patients with PA-IVS who have univentricular and biventricular circulation? Participants will be asked to answer a Quality of Life questionnaire. The investigators will also inquire with a sample size of the research subjects (based on place of residence) about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram, magnetic resonance of the heart and blood sampling to assess cardiac function and cardiac health).
Primary outcome measures
- Difference in comorbidity between the two groups [Time frame: September 2024]
Secondary outcome measures (5)
- Difference in quality of life between the two groups [Time frame: September 2024]
- Difference in physical capacity between the two groups [Time frame: September 2024]
- Difference in cardiac capacity between the two groups [Time frame: September 2024]
- Difference in general health, linked to cardiac health, between the two groups [Time frame: September 2024]
- Difference in mortality between the groups [Time frame: September 2024]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Pediatric Heart Center, Queen Silvia's Children's hospital — Gothenburg
Identifiers
NCT: NCT05928234 · PA-IVS, 2023