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
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pulmonary Atresia With Intact Ventricular Septum
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Difference in comorbidity between the two groups
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Investigators
Stina Manhem
MD
Vastra Gotaland Region
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.
Outcomes
Primary Outcomes
Difference in comorbidity between the two groups
Time Frame: September 2024
Difference in myocardial infarction, heart failure, arrhythmia, stroke, malignancy, autoimmune diseases, infections, atopy, certain liver diseases, and protein-losing enteropathy between the two groups
Secondary Outcomes
- Difference in physical capacity between the two groups(September 2024)
- Difference in quality of life between the two groups(September 2024)
- Difference in mortality between the groups(September 2024)
- Difference in cardiac capacity between the two groups(September 2024)
- Difference in general health, linked to cardiac health, between the two groups(September 2024)