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Blood test could offer gentler way to track Children's heart disease

NCT ID NCT01873976

Knowledge-focused Sponsor: Wayne State University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study looks at whether natural substances in the blood, called cardiac biomarkers, can help doctors manage children with cardiomyopathy—a disease of the heart muscle. The goal is to see if these blood tests could be a less invasive alternative to echocardiograms or MRIs for detecting heart problems and guiding treatment decisions, such as when a heart transplant might be needed. Researchers will follow children with dilated or hypertrophic cardiomyopathy and track outcomes like time to death, need for transplant, or worsening heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cardiac biomarker blood tests
What this could lead to
If these blood tests prove reliable, they could help doctors monitor children with cardiomyopathy more easily and decide when a heart transplant might be needed.
What could go wrong
This is an observational study, so it won't test a treatment. The biomarkers may not be accurate enough to replace current imaging methods, and results may vary across different types of cardiomyopathy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

288 people

The number who actually took part.

Started

Jun 2013

Finished

Jun 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric cases of dilated and hypertrophic cardiomyopathy will be recruited at 11 pediatric cardiology centers in the US and Canada.

Ages

Up to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient is alive and has not received a transplant prior to enrollment in the study. * Under age 21 years at age of enrollment * For Group 1 (incident DCM), a case of DCM presenting to a study site within 2 years of the original cardiomyopathy diagnosis * Group 2 (incident/recent HCM), a new or existing diagnosis of idiopathic or familial HCM with a cMRI within 12 months of diagnosis * Group 3 (prevalent HCM or DCM), any child with a diagnosis of DCM or idiopathic, familial, or HCM due to a known disease-causing mutation who has survived transplant-free at least 12 months from the date of original cardiomyopathy diagnosis * For all 3 groups, diagnosis of cardiomyopathy must be confirmed by Echocardiographic or cMRI criteria Exclusion Criteria: A patient is not eligible for enrollment if one or more of the following conditions are met at the time of presentation with cardiomyopathy: * Any cardiomyopathy diagnosis other than DCM or idiopathic HCM, familial HCM or HCM due to a known disease-causing gene * Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers) * History of rheumatic fever * Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure) * HIV infection or born to an HIV positive mother * Kawasaki disease * Congenital heart defects unassociated with malformation syndromes (e.g., valvular heart disease or congenital coronary artery malformations) * Immunologic disease * Invasive cardiothoracic procedures or major surgery during the preceding month, except those specifically related to cardiomyopathy including left ventricular assist device (LVAD), extracorporeal membrane oxygenator (ECMO), and automatic implantable cardioverter defibrillator (AICD) placement * Uremia, active or chronic * Abnormal ventricular size or function that can be attributed to intense physical training or chronic anemia * Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) * Malignancy * Systemic Hypertension * Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) * Ischemic coronary vascular disease * Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy

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Conditions

The condition(s) this trial relates to.

dilated cardiomyopathy hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dilated cardiomyopathy Hypertrophic cardiomyopathy

Contacts and locations

Locations

  • Ann and Robert H. Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467, United States

  • Children's Hospital of New York, Columbia Presbyterian Medical Center

    New York, New York, 10032, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh of UMPC

    Pittsburgh, Pennsylvania, 15224, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113, United States

  • Stollery Children's Hospital, University of Alberta

    Edmonton, Alberta, T6G 2B7, Canada

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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