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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Scott S. Oh, DO, FCCP, DAABIP，University of California, Los Angeles

Tracking Information

First Submitted Date ^ICMJE

September 11, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]

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

Incidence of hospitalizations and emergency room encounters[ Time Frame: 1 year post-enrollment ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

All cause mortality[ Time Frame: 1 year post-enrollment ]
All cause mortality
New York Heath Association (NYHA) functional class[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]
NYHA functional class: I, III, III, or IV
Incidence of pleural procedures[ Time Frame: 1 year post-enrollment ]
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.
Incidence of pleural space or chest wall infection[ Time Frame: 1 year post-enrollment ]
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.
Incidence of hemothorax[ Time Frame: 1 year post-enrollment ]
Hemothorax is defined as a pleural hematocrit or red blood cell count (RBC) exceeding 50% that of the serum hematocrit or RBC count.
Incidence of trapped lung, loculated pleural effusion, and pneumothorax[ Time Frame: 1 year post-enrollment ]
Trapped lung is defined as a lung that does not expand after pleural fluid drainage leaving a pneumothorax ex-vacuo or hydropneumothorax. Pneumothorax and loculated pleural effusion will be determined based on classic imaging characteristics.
Incidence of pleurodesis[ Time Frame: 1 year post-enrollment ]
Incidence of pleurodesis over the one year after enrollement will be measured. Pleurodesis is defined as apposition of the parietal and visceral pleural such: (i) that the subject drains less than 10cc on three serial drainages, (ii) there is resolution of the pleural effusion on both chest x-ray (CXR) and chest ultrasound, (iii) the TPC is removed, and (iv) the pleural effusion does not accumulate after TPC removal as evidence by CXR and chest ultrasound.
Time to pleurodesis among those who achieved pleurodesis[ Time Frame: 1 year post-enrollment ]
The number of days from enrollment (control group) or TPC placement (intervention group) to pleurodesis among those who achieved pleurodesis will be recorded. Pleurodesis is defined as apposition of the parietal and visceral pleural such: (i) that the subject drains less than 10cc on three serial drainages, (ii) there is resolution of the pleural effusion on both chest x-ray (CXR) and chest ultrasound, (iii) the TPC is removed, and (iv) the pleural effusion does not accumulate after TPC removal as evidence by CXR and chest ultrasound.
Change from baseline serum albumin[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]
serum albumin levels
Change from baseline serum creatinine[ Time Frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months) ]
serum creatinine levels
Rate of hemodialysis initiation[ Time Frame: 1 year post-enrollment ]
We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be an intervention group (receiving the tunneled pleural catheter) and a usual care group.
Masking: Interventional
Masking Description:The subjects and providers will not be blinded, since it will be apparent which patients received a pleurx catheter. Outcomes measured by survey and chart review will be scored and analyzed in a blinded fashion.
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

Device: tunneled pleural catheter
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.

Study Arms

Experimental: Intervention Group
This group will receive placement of a tunneled pleural catheter to drain their recurrent, chronic, and symptomatic pleural effusion in addition to their usual medication therapy.
No Intervention: Usual Care
The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

210

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 30, 2020

Estimated Primary Completion Date

September 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Scott S. Oh, DO, FCCP, DAABIP，University of California, Los Angeles

Study Sponsor ^ICMJE

University of California, Los Angeles

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of California, Los Angeles

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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