NCT07361536

Brief Summary

The purpose of this study is to better understand how heart and blood vessel problems develop in people with Mucopolysaccharidosis (MPS). The investigators are looking at certain substances in the body called GAGs and proteoglycans to see how they affect the heart. The investigators also want to find reliable blood and urine markers that can help us track heart health and guide future treatments. This study aims to answer two main questions:

  • Carotid ultrasound: an imaging test that looks at the blood vessels in the neck.
  • Echocardiogram: an ultrasound of the heart.
  • Blood draw
  • Urine collection These tests help the investigators track changes in heart and blood vessel health over time.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress15%
Sep 2025Apr 2030

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

January 21, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

mucopolysaccharidosiscarotidcardiovascularbiomarkerobservational

Outcome Measures

Primary Outcomes (1)

  • Cardiac and Carotid Structure and Function

    1\) We aim to annually assess cardiac and carotid structure and function utilizing ultrasonography, in participants with mucopolysaccharidoses and matched control participants

    Year 1, Year 2, Year 3, and Year 4

Secondary Outcomes (1)

  • Measure biomarkers

    Year 1, Year 2, Year 3, and Year 4

Study Arms (2)

MPS

Participants diagnosed with MPS I or MPS IVA

Control

Participants who do not have an MPS diagnosis

Eligibility Criteria

Age0 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be drawn from each participating site's existing patient population. Eligible individuals who meet protocol-defined criteria and are willing to take part in annual study visits will be invited to enroll. The study population will therefore consist of patients receiving care at the participating institutions who consent to ongoing observational follow-up.

You may qualify if:

  • Any Participant with a molecularly confirmed diagnosis of mucopolysaccharidosis is eligible to enroll in this study
  • Any healthy participant without a diagnosis of mucopolysaccharidosis whose age and biological sex can be matched with an enrolled mucopolysaccharidosis participant
  • Parental / patient informed consent

You may not qualify if:

  • Any reason that the investigators would deem a patient not eligible to participate in this study
  • Inability to participate in the assessments required for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children'S Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

NOT YET RECRUITING

Saint Louis University

St Louis, Missouri, 63104, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Plasma * Urine

MeSH Terms

Conditions

Mucopolysaccharidosis IVMucopolysaccharidoses

Condition Hierarchy (Ancestors)

Carbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 23, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations