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

University of California, Los Angeles

Overview

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.

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. All trial participants will be adults with congestive heart failure (CHF) already managed with maximal medical therapy, as determined by their cardiologist or primary physician. Patients will demonstrate recurrent transudative or pseudoexudative pleural effusions caused solely by CHF that have not been controlled with medical therapy alone. Included patients must also show documented subjective symptomatic relief with thoracentesis. Patients will be randomized to the intervention group or control group. The intervention group will receive a tunneled pleural catheter (TPC) in addition to their current medical treatment. The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate. Patients will then be followed over the course of once year after enrollment. The TPC will be drained daily for symptomatic relief. Several outcomes, including quality of life based on periodic self-survey and healthcare utilization determined by chart review (emergency room visits and hospital stays), will be studied. Adverse outcomes of TPC insertion and sequelae of frequent pleural space drainage will be documented.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Pleural Effusions, Chronic Congestive Heart Failure Shortness of Breath

Interventions

tunneled pleural catheterDEVICE

Placement of a tunneled pleural catheter through the chest wall into the pleural space to drain the patient's chronic pleural effusion. The catheter is an indwelling device that will be drained from home three times per week by nursing care, the patient, or patient's family.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 18 years of age at enrollment 2. Able to give consent 3. Documented heart failure defined by echocardiography demonstrating depressed left ventricular ejection fraction and/or left ventricular diastolic dysfunction 4. Recurrent and symptomatic pleural effusions refractory to medical management 5. 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 6. Documented subjective symptomatic relief after thoracentesis and drainage of the pleural space 7. Pleural fluid clinically determined to be due only to CHF 8. 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 9. Anticipated outpatient management Exclusion Criteria: 1. Imminent death within 1 month 2. Heart transplant candidate 3. Lone right sided heart failure with normal left sided cardiac function 4. Active malignancy 5. Active pulmonary infection 6. Alternate etiology for pleural effusion origin 7. On hemodialysis during enrollment 8. Exudative pleural effusion, defined as any effusion that dose not meet criteria for transudate or pseudoexudate 9. Contraindication for TPC insertion

Locations (1)

UCLA Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire

Quality of life will be measured by the Minnesota Living with Heart Failure Questionnaire at four time points

Time frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)

Incidence of hospitalizations and emergency room encounters

Measurement of all significant health care visits, including hospitalizations and emergency room encounters

Time frame: 1 year post-enrollment

Secondary Outcomes

All cause mortality

Time frame: 1 year post-enrollment

New York Heath Association (NYHA) functional class

NYHA functional class: I, III, III, or IV

Time frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)

Incidence of pleural procedures

By convention, the intervention group will have one pleural procedure (TPC placement). Any additional thoracenteses, video-assisted thoracoscopic surgery, or chest tubes on either side of the chest will be documented for both groups. Removal of or manipulation of TPC will not be recorded as an additional pleural procedure.

Time frame: 1 year post-enrollment

Incidence of pleural space or chest wall infection

Pleural space infection is defined as a positive pleural fluid culture. Chest wall infection will be defined clinically, based on the presence of cellulitis surrounding the catheter or catheter tract, or pus draining from the catheter insertion site.

Time frame: 1 year post-enrollment

Data from ClinicalTrials.gov

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