Apply to Trial

Compensation: Varies

Number of Visits: 1

Duration: 9 days

50 Participants Needed

Propranolol for Chylothorax

Overseen ByShannon Brackett, NP

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: June Wu

Must be taking: Propranolol

Must not be taking: Chronic bronchodilators

Disqualifiers: Pregnancy, Renal failure, Asthma, others

Trial Summary

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants can continue their ongoing treatments and start new ones for their primary cardiac or other medical conditions during the trial.

What data supports the effectiveness of the drug propranolol for treating chylothorax?

Research shows that propranolol helped improve chylothorax in infants, with some cases resolving before birth and others showing improvement after starting the drug. This suggests propranolol could be a promising option for managing chylothorax.¹ ² ³ ⁴ ⁵

Is propranolol generally safe for use in humans?

Propranolol has been used safely in various conditions, including chylothorax in infants and prevention of esophageal varices bleeding in adults, with no significant adverse effects reported in these studies.¹ ² ³ ⁶ ⁷

How does the drug propranolol differ from other treatments for chylothorax?

Propranolol is unique because it is a nonselective beta-blocker that has shown promise in treating chylothorax, a condition with no well-established medical therapies, by potentially improving lymphatic function and reducing pleural effusion. Unlike other treatments like octreotide, which can have serious side effects, propranolol has been used safely in both prenatal and postnatal settings, showing improvement in clinical signs without significant complications.¹ ² ³ ⁸ ⁹

What is the purpose of this trial?

Postoperative chylothorax is a serious complication after open heart surgery for pediatric patients with congenital heart disease (CHD). While it was thought to be mechanical injury to the thoracic duct, recent research demonstrated that there are intrinsically abnormal lung lymphatics in CHD patients, and after open heart surgery, the fluid shifts that occur overwhelms these abnormal lung lymphatics. As a result, postoperative chylothorax occurs. Propranolol has been found to be helpful in resolving postoperative chylothorax very quickly (9 days) in a subset of postoperative chylothorax patients (60%). However, it is not known why some patients respond and some do not. The investigators hypothesize that propranolol is safe to use in this patient population, and that certain clinical factors will predict propranolol response, but more importantly, some clinical factors can be optimize to allow more patients with postoperative chylothorax to respond to and benefit from propranolol. In order to improve the understanding of how propranolol works and to maximize benefit to patients, the investigators propose to perform a prospective, randomized, double-blind clinical trial to learn how to best use propranolol in patients with postoperative chylothorax.

Research Team

June Wu, MD

Principal Investigator

Columbia University Irving Medical Center/ New York Presbyterian hospital

Eligibility Criteria

This trial is for pediatric patients with congenital heart disease who have developed chylothorax after open heart surgery. The study aims to include those who may benefit from Propranolol treatment. Specific eligibility criteria are not provided, but typically would involve age and health status considerations.

Inclusion Criteria

My kidneys work well and I'm not on dialysis.

Must also be enrolled in a related study (AAAQ6902) which collects chylothorax fluid for cell isolation and genetic analysis

Must have ≥70% lymphocytes or pleural triglyceride (TG) ≥ half of serum TG, or chylomicron positive

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Exclusion Criteria

My slow heartbeat cannot be corrected with a pacemaker.

Pregnancy

I am experiencing kidney failure.

See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive propranolol or placebo for 9 days after reaching the lowest effective goal dose

9 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including daily blood pressure, heart rate, and glucose level measurements

24 days

Regular monitoring (in-person)

Open-label extension

Participants in the placebo group with <80% reduction in chylothorax drainage receive propranolol for 9 days in an open-label setting

9 days

Treatment Details

Interventions

Propranolol

Trial Overview The trial is testing the effectiveness of Propranolol Hydrochloride in treating postoperative chylothorax against a placebo. It's a randomized, double-blind study which means participants will be randomly assigned to receive either the medication or an inactive substance without knowing which one they're getting.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Propranolol hydrochlorideActive Control1 Intervention

Subjects will be randomized to receive 2mg/kg/day. Propranolol will be administered orally, either as a tablet or as a solution, in equal divided doses three times a day.

Group II: PlaceboPlacebo Group1 Intervention

Placebo suspension will only have Ora-Blend