Propranolol for Chylothorax

Recruiting at 1 trial location

Overseen By Shannon 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

Compensation: Varies

Number of Visits: 1

Duration: 9 days

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if propranolol, a common heart medication, can aid children and teens in recovering from chylothorax, a condition causing fluid buildup in the chest after heart surgery for congenital heart defects. Researchers seek to understand why some patients respond well to propranolol while others do not, and they are testing whether adjusting treatment factors can improve outcomes. Participants will receive either propranolol or a placebo to compare results. Children and teens who have undergone heart surgery and are experiencing significant fluid drainage in the chest are suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how propranolol works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that propranolol is likely to be safe for humans?

Research shows that propranolol is a relatively safe option for treating fluid buildup in unborn babies and newborns. In past studies, propranolol successfully cleared fluid in the chest after surgery in about 60% of patients within nine days. This indicates that propranolol is generally well-tolerated and can work quickly to help patients.

Propranolol is already used for other health conditions, which provides some confidence about its safety. It is generally considered effective and safe for its approved uses. Since this trial is in the early stages, the researchers are cautious, but current evidence supports propranolol's safety for similar health issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using propranolol for chylothorax because it offers a novel approach compared to traditional treatments like dietary modifications, drainage, or surgery. Propranolol is a beta-blocker that may help reduce lymphatic flow, which is the underlying issue in chylothorax. This unique mechanism of action could provide a less invasive and more efficient treatment option, potentially improving outcomes and quality of life for patients with this condition.

What is the effectiveness track record for propranolol in treating postoperative chylothorax?

Research has shown that propranolol can help treat postoperative chylothorax, a condition where lymphatic fluid accumulates in the chest, often after heart surgery in children with congenital heart disease. In past studies, about 60% of patients experienced rapid improvement, typically within 9 days, when treated with propranolol. In this trial, participants will be randomized to receive either propranolol or a placebo. Propranolol may shorten the duration of chest tube use and reduce complications for those who respond well to the treatment. However, the reasons why some patients respond to the treatment while others do not remain unclear. Understanding these differences could lead to better treatment outcomes for more patients. ^{1 2 3 4 6}

Who Is on the Research Team?

June Wu, MD

Principal Investigator

Columbia University Irving Medical Center/ New York Presbyterian hospital

Are You a Good Fit for This Trial?

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

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

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

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

Exclusion Criteria

My slow heartbeat cannot be corrected with a pacemaker.

Pregnancy

I am experiencing kidney failure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Propranolol hydrochloride Active Control 1 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: Placebo Placebo Group 1 Intervention

Placebo suspension will only have Ora-Blend

Who Is Running the Clinical Trial?

June Wu

Lead Sponsor

Trials

1

Recruited

50+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11472413/

Propranolol As a Treatment Option for Chylous Effusions and ... Propranolol is a relatively effective and safe treatment option for chylous effusion and chylous ascites that can be administered prenatally or to neonates.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06833320?cond=Congenital%20chylothorax%20OR%20%22%22&aggFilters=status:not%20rec&viewType=Table&rank=1

Propranolol Treatment for Postoperative Chylothorax Propranolol has been found to be helpful in resolving postoperative chylothorax very quickly (9 days) in a subset of postoperative chylothorax patients (60%).

3. withpower.com withpower.com/trial/phase-2-chylothorax-2-2025-33c92

Propranolol for Chylothorax Propranolol has been found to be helpful in resolving postoperative chylothorax very quickly (9 days) in a subset of postoperative chylothorax patients (60%).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34583843/

Propranolol treatment for chylothorax after congenital ... Responders to propranolol had significantly less morbidity and duration of chest tube requirement when compared with control patients and nonresponders.

5. smartpatients.com smartpatients.com/trials/NCT06833320

Propranolol Treatment for Postoperative Chylothorax As a result, postoperative chylothorax occurs. Propranolol has been found to be helpful in resolving postoperative chylothorax very quickly (9 days) in a subset ...

6. profiles.wustl.edu profiles.wustl.edu/en/publications/propranolol-for-the-treatment-of-lymphatic-malformations-in-a-neo/

Propranolol for the treatment of lymphatic malformations in ... Clinical improvement was not seen until the initiation of treatment with oral propranolol at a maximum dosage of 0.5 mg/kg/day divided every 8 hours with ...