Clinical trial NCT03696524: Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial
Official title: Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pleural Effusions, Chronic
Congestive Heart Failure
Shortness of Breath
Keywords: congestive heart failure
pleural effusion
shortness of breath
tunneled pleural catheter
thoracentesis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be an intervention group (receiving the tunneled pleural catheter) and a usual care group.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire
timeFrame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
measure: Incidence of hospitalizations and emergency room encounters
timeFrame: 1 year post-enrollment
Secondary outcomes:
measure: All cause mortality
timeFrame: 1 year post-enrollment
measure: New York Heath Association (NYHA) functional class
timeFrame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
measure: Incidence of pleural procedures
timeFrame: 1 year post-enrollment
measure: Incidence of pleural space or chest wall infection
timeFrame: 1 year post-enrollment
measure: Incidence of hemothorax
timeFrame: 1 year post-enrollment
measure: Incidence of trapped lung, loculated pleural effusion, and pneumothorax
timeFrame: 1 year post-enrollment
measure: Incidence of pleurodesis
timeFrame: 1 year post-enrollment
measure: Time to pleurodesis among those who achieved pleurodesis
timeFrame: 1 year post-enrollment
measure: Change from baseline serum albumin
timeFrame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
measure: Change from baseline serum creatinine
timeFrame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
measure: Rate of hemodialysis initiation
timeFrame: 1 year post-enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
References:
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