Could a common heart drug fix a rare surgery complication in kids?
NCT ID NCT06833320
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether propranolol, a drug often used for high blood pressure, can safely treat chylothorax—a buildup of lymphatic fluid—in children after open heart surgery. About 50 children aged 7 days to 18 years with congenital heart disease will receive either propranolol or a placebo. The goal is to see if the drug helps resolve the fluid leak faster and to identify which patients benefit most.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Propranolol
- What this could lead to
- If it works, this could provide a safe, non-surgical treatment for a serious complication after heart surgery in children.
- What could go wrong
- This is an early-phase trial with only 50 participants, and it is currently suspended. Not all patients responded in earlier studies, and side effects like low blood pressure or low blood sugar are possible.
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.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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7 days to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * ≥7 days and ≤18 years old at time of original cardiac surgery * Congenital structural cardiac anomaly necessitating surgical correction. Examples include but are not limited to: ASD, VSD, single ventricles, HLHS, Tetralogy of Fallot, transposition of great vessels, AV canal, heart transplant * developed high output postoperative chylothorax (≥10mL/kg/day), or * persistent chylous drainage at any volume for ≥7 days after open heart surgery for a congenital cardiac defect * ≥70% lymphocytes, or * pleural triglyeride (TG) ≥ half of serum TG, or chylomicron positive * for patients with lower than normal serum lymphocyte count (agedependent), ≥60% lymphocytes in pleural fluids * Must have measurable output (chylothorax output in mL) * Any level of respiratory support (room air, supplemental oxygen, CPAP/BIPAP, ventilatory support) * Any level of inpatient support (ICUs, step-down units, floor) * Study participants can be on concomitant treatment for postoperative chylothorax started prior to study initiation * Study participants can continue on on-going treatment for their primary cardiac other medical conditions * Study participants can initiate new treatments for their primary cardiac or other medical conditions during trial period * Adequate renal function * Not on dialysis * No hemodynamically unstable bradycardia * No systolic hypotension not corrected by pressor support * Not in 2nd or 3rd degree heart block * No history of asthma * A parent or a legal guardian must sign a written informed consent and HIPAA Form * Patients will be required to also be enrolled in a related study (AAAQ6902) which collects chylothorax fluid for cell isolation and genetic analysis Exclusion Criteria: * Pregnancy * Renal failure at time of enrollment * Hypotension despite pressor support * Unstable bradycardia without capacity for pacing * History of asthma or chronic bronchodilator therapy * Uncontrolled hypoglycemia or hyperglycemia as per investigators' judgment * Study participant will be removed from study if they failed 2 consecutive attempts to initiate propranolol (\>10% drop in BP/HR from age-adjusted normative range) * Study participant experiences ≥ Grade 3 AE (SAE)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center/NewYork-Presbyterian
New York, New York, 10032, United States
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