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

Primary Purpose

Pleural Effusions, Chronic, Congestive Heart Failure, Shortness of Breath

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

tunneled pleural catheter

About this trial

This is an interventional supportive care trial for Pleural Effusions, Chronic focused on measuring congestive heart failure, pleural effusion, shortness of breath, tunneled pleural catheter, thoracentesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Usual Care

Arm Description

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.

The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate.

Outcomes

Primary Outcome Measures

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

Incidence of hospitalizations and emergency room encounters

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

Secondary Outcome Measures

All cause mortality

New York Heath Association (NYHA) functional class

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

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.

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.

Incidence of hemothorax

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

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

Incidence of pleurodesis over the one year after enrollment 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

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

serum albumin levels

Change from baseline serum creatinine

serum creatinine levels

Rate of hemodialysis initiation

We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis

Full Information

NCT ID

NCT03696524

First Posted

September 11, 2018

Last Updated

April 3, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03696524

Brief Title

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

Acronym

TREAT-CHF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of enrollment

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleural Effusions, Chronic, Congestive Heart Failure, Shortness of Breath

Keywords

congestive heart failure, pleural effusion, shortness of breath, tunneled pleural catheter, thoracentesis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

There will be an intervention group (receiving the tunneled pleural catheter) and a usual care group.

Masking

Outcomes Assessor

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.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate.

Intervention Type

Device

Intervention Name(s)

tunneled pleural catheter

Other Intervention Name(s)

pleurx catheter placement

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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)

Title

Incidence of hospitalizations and emergency room encounters

Description

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

Time Frame

1 year post-enrollment

Secondary Outcome Measure Information:

Title

All cause mortality

Description

All cause mortality

Time Frame

1 year post-enrollment

Title

New York Heath Association (NYHA) functional class

Description

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)

Title

Incidence of pleural procedures

Description

Time Frame

1 year post-enrollment

Title

Incidence of pleural space or chest wall infection

Description

Time Frame

1 year post-enrollment

Title

Incidence of hemothorax

Description

Hemothorax is defined as a pleural hematocrit or red blood cell count (RBC) exceeding 50% that of the serum hematocrit or RBC count.

Time Frame

1 year post-enrollment

Title

Incidence of trapped lung, loculated pleural effusion, and pneumothorax

Description

Time Frame

1 year post-enrollment

Title

Incidence of pleurodesis

Description

Time Frame

1 year post-enrollment

Title

Time to pleurodesis among those who achieved pleurodesis

Description

Time Frame

1 year post-enrollment

Title

Change from baseline serum albumin

Description

serum albumin levels

Time Frame

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

Title

Change from baseline serum creatinine

Description

serum creatinine levels

Time Frame

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

Title

Rate of hemodialysis initiation

Description

We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis

Time Frame

1 year post-enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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24726601

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

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