NCT05979870

Brief Summary

The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates. The main question\[s\] it aims to answer are:

  • \[question 1\]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve
  • \[question 2\]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term. Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Oct 2022Dec 2028

Study Start

First participant enrolled

October 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

July 31, 2023

Last Update Submit

May 12, 2025

Conditions

Aortic Valve DiseasePulmonary Valve DiseaseChild, OnlyMagnetic Resonance ImagingRisk Stratification

Outcome Measures

Primary Outcomes (2)

  • CMR measures

    Measurement by CMR of changes in ventricular function, remodelling, tissue characterisation and advanced four dimensional flow (4D-flow) measurements after surgery or intervention

    Before and after 6 months, 1 year and up to 3 years after intervention or surgery

  • Physical capacity

    Measurement of physical capacity after surgery or intervention, by cardiopulmonary exercise testing (CPET)

    Before and after 6 months, 1 year and up to 3 years after intervention or surgery

Secondary Outcomes (1)

  • CMR derived flow measurements near metallic implants, stents

    after 6 months, 1 year and up to 3 years after intervention

Study Arms (4)

Aortic valve disease-operation

Surgery of the aortic valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.

Procedure: Valvuloplasty,

Aortic valve disease-intervention

Interventional treatment of the aortic valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.

Procedure: Valvuloplasty,

Pulmonary valve disease-operation

Surgery of the pulmonary valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.

Procedure: Valvuloplasty,

Pulmonary valve disease-intervention

Interventional treatment of the pulmonary valve: Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment

Procedure: Valvuloplasty,

Interventions

Valvuloplasty,PROCEDURE

Choice of type of intervention decided on a multidisciplinary conference

Also known as: surgical valvular repair
Aortic valve disease-interventionAortic valve disease-operationPulmonary valve disease-interventionPulmonary valve disease-operation

Eligibility Criteria

Age1 Week - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Childen aged 0-18 years old with aortic or pulmonary valve disease in need of treatment admitted to the Paediatric Heart Centre, Queen Silvia Childrens' Hospital, Gothenburg Sweden. Patients will be invited to participate in the study after a multidisciplinary conference on decision of treatment

You may qualify if:

  • aortic valve disease
  • or pulmonary valve disease
  • clinical indication for valvular surgery
  • or clinical indication for valvular intervention

You may not qualify if:

  • contraindications for MRI
  • need of sedation or general anesthesia, unless there is a clinical indication for a CMR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Silvia Children'sHospital, Sahlgrenska University Hospital

Gothenburg, Gothenburg, 41560, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Balloon Valvuloplasty

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsInvestigative Techniques

Study Officials

  • Charlotte de Lange, MD, Assoc. Prof

    Sahlgrenska University hospital, Queen Silvia Childrens' Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Associate Professor, senior consultant

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

October 1, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

SE(1)