Open Actively Recruiting

Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial

About

Brief Summary

Congestive heart disease (CHF) can frequently cause transudative pleural effusions, some of which do not completely resolve with diuretics alone. These effusions can cause significant morbidity, leading to ongoing dyspnea and hypoxia, resulting in additional office and hospital visits. TREAT-CHF is a randomized trial studying tunneled pleural catheter (TPC) versus standard medical management for the treatment recurrent symptomatic pleural effusions secondary to CHF that are refractory to maximal medical therapy. TREAT-CHF will study whether the addition of a TPC can improve quality of life and minimize health care utilization over the one year following insertion.

Primary Purpose
Supportive Care
Study Type
Interventional
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Age > 18 years of age at enrollment
  • Able to give consent
  • Documented heart failure defined by echocardiography demonstrating depressed left ventricular ejection fraction and/or left ventricular diastolic dysfunction
  • Recurrent and symptomatic pleural effusions refractory to medical management
  • Maximal medical management will be determined by the referring provider a. This should include use of at least three of the classes of medications that are standard of care for heart failure: i. Angiotensin converting enzyme inhibitor or angiotensin receptor blockers ii. Beta blockers iii. Loop diuretics iv. Potassium-sparing diuretics b. If the patient is not on at least three drugs from the above classes, documentation of drug intolerance must be present
  • Documented subjective symptomatic relief after thoracentesis and drainage of the pleural space
  • Pleural fluid clinically determined to be due only to CHF
  • Pleural fluid analysis consistent with transudate or pseudoexudate a. Transudate: defined by Light's criteria, all of the following must occur, i. Pleural:serum lactate dehydrogenase (LDH) < 0.6 ii. Pleural LDH < 2/3 x upper limit of normal of serum LDH iii. Pleural:serum protein < 0.5 b. Pseudoexudate: defined by all of the following, i. Pleural:serum LDH > 0.6 but < 1 ii. Pleural:serum protein < 0.5 iii. Serum-pleural protein gradient > 3.2 and/or serum-pleural albumin gradient > 1.2
  • Anticipated outpatient management

Exclusion Criteria:

  • Imminent death within 1 month
  • Heart transplant candidate
  • Lone right sided heart failure with normal left sided cardiac function
  • Active malignancy
  • Active pulmonary infection
  • Alternate etiology for pleural effusion origin
  • On hemodialysis during enrollment
  • Exudative pleural effusion, defined as any effusion that dose not meet criteria for transudate or pseudoexudate
  • Contraindication for TPC insertion

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Study Stats
Protocol No.
18-000400
Category
Pulmonary Disease
Contact
Kathryn Melamed
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03696524
For detailed technical eligibility, visit ClinicalTrials.gov.