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A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05928234
Collaborator
(none)
140
Enrollment
15
Anticipated Duration (Months)

Study Details

Study Description

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 all research subjects about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram and blood sampling to assess cardiac function and cardiac health).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    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
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Biventricular circulation

    Research subjects with PA-IVS who have biventricular circulation
    Univentricular circulation

    Research subjects with PA-IVS who have univentricular circulation

    Outcome Measures

    Primary Outcome Measures

    1. Difference in comorbidity between the two groups [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 Outcome Measures

    1. Difference in quality of life between the two groups [September 2024]

      A validated quality of life questionnaire (PROMIS Scale v1.2-Global Health) will be sent to all the research subjects and the answers will be compared between the two groups. The questionnaire consists of a ten-item patient reported measure of physical, mental and social health. Each statement is answered on a scale from 1-5, higher scores mean better outcome.

    2. Difference in physical capacity between the two groups [September 2024]

      Ergospirometry, outcome variables: exercise test (exercise capacity measured in watt and over time, counted in minutes), oxygen saturation (measured in percent), blood pressure (measured in millimetre of mercury)

    3. Difference in cardiac capacity between the two groups [September 2024]

      Transthoracic echocardiogram

    4. Difference in general health, linked to cardiac health, between the two groups [September 2024]

      The following blood tests will be analysed: N-terminal pro-brain natriuretic peptide (a marker for heart failure), Alanine aminotransferase (a liver enzyme), Aspartate aminotransferase (a liver enzyme), Creatinine (a waste product from muscle metabolism, used to assess kidney function), Sodium (an electrolyte), Potassium (an electrolyte), Hemoglobin (a protein in red blood cells that carries oxygen), White blood cell count (Leukocyte count), Platelet count (Thrombocyte count), Albumin: A protein produced by the liver that helps maintain fluid balance in the body, TREC (T-receptor excision circles): A marker used to assess immune function, specifically the production of new T cells, Expanded lymphocyte typing (a comprehensive examination of lymphocyte subtypes)

    5. Difference in mortality between the groups [September 2024]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Vastra Gotaland Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Stina Manhem, MD, Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT05928234
    Other Study ID Numbers:
    • PA-IVS, 2023
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Atresia
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Jul 3, 2023