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

NCT03696524 | Withdrawn FDA Device

• 1 other identifier: 18-000400
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 year post-enrollment

Secondary Outcomes (11)

• All cause mortality

  1 year post-enrollment

• New York Heath Association (NYHA) functional class

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

• Incidence of pleural procedures

  1 year post-enrollment

• Incidence of pleural space or chest wall infection

  1 year post-enrollment

• Incidence of hemothorax

  1 year post-enrollment

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Device: tunneled pleural catheter

Usual Care

NO INTERVENTION

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

Interventions

tunneled pleural catheter DEVICE

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.

Also known as: pleurx catheter placement

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (18)

• Freeman RK, Ascioti AJ, Dake M, Mahidhara RS. A propensity-matched comparison of pleurodesis or tunneled pleural catheter for heart failure patients with recurrent pleural effusion. Ann Thorac Surg. 2014 Jun;97(6):1872-6; discussion 1876-7. doi: 10.1016/j.athoracsur.2014.02.027. Epub 2014 Apr 14.

  PMID: 24726601 BACKGROUND

• Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.

  PMID: 20696691 BACKGROUND

• Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.

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• Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.

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• Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.

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• Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.

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  PMID: 13381740 BACKGROUND

• Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.

  PMID: 22179539 BACKGROUND

• Majid A, Kheir F, Fashjian M, Chatterji S, Fernandez-Bussy S, Ochoa S, Cheng G, Folch E. Tunneled Pleural Catheter Placement with and without Talc Poudrage for Treatment of Pleural Effusions Due to Congestive Heart Failure. Ann Am Thorac Soc. 2016 Feb;13(2):212-6. doi: 10.1513/AnnalsATS.201507-471BC.

  PMID: 26598967 BACKGROUND

• Krishnan M, Cheriyath P, Wert Y, Moritz TA. The Untapped Potential of Tunneled Pleural Catheters. Ann Thorac Surg. 2015 Dec;100(6):2055-7. doi: 10.1016/j.athoracsur.2015.05.086. Epub 2015 Aug 18.

  PMID: 26294344 BACKGROUND

• Srour N, Potechin R, Amjadi K. Use of indwelling pleural catheters for cardiogenic pleural effusions. Chest. 2013 Nov;144(5):1603-1608. doi: 10.1378/chest.13-0331.

  PMID: 23807028 BACKGROUND

• Chalhoub M, Harris K, Castellano M, Maroun R, Bourjeily G. The use of the PleurX catheter in the management of non-malignant pleural effusions. Chron Respir Dis. 2011;8(3):185-91. doi: 10.1177/1479972311407216. Epub 2011 Jun 2.

  PMID: 21636653 BACKGROUND

• Chakko SC, Caldwell SH, Sforza PP. Treatment of congestive heart failure. Its effect on pleural fluid chemistry. Chest. 1989 Apr;95(4):798-802. doi: 10.1378/chest.95.4.798.

  PMID: 2924609 BACKGROUND

• Romero-Candeira S, Fernandez C, Martin C, Sanchez-Paya J, Hernandez L. Influence of diuretics on the concentration of proteins and other components of pleural transudates in patients with heart failure. Am J Med. 2001 Jun 15;110(9):681-6. doi: 10.1016/s0002-9343(01)00726-4.

  PMID: 11403751 BACKGROUND

• Roth BJ, O'Meara TF, Cragun WH. The serum-effusion albumin gradient in the evaluation of pleural effusions. Chest. 1990 Sep;98(3):546-9. doi: 10.1378/chest.98.3.546.

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• Bottle A, Goudie R, Bell D, Aylin P, Cowie MR. Use of hospital services by age and comorbidity after an index heart failure admission in England: an observational study. BMJ Open. 2016 Jun 9;6(6):e010669. doi: 10.1136/bmjopen-2015-010669.

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• Kawano H, Arakawa S, Satoh O, Matsumoto Y, Hayano M, Nakatomi D, Yamasa T, Maemura K. Effect of pimobendan in addition to standard therapy for heart failure on prevention of readmission in elderly patients with severe chronic heart failure. Geriatr Gerontol Int. 2014 Jan;14(1):109-14. doi: 10.1111/ggi.12067. Epub 2013 Apr 15.

  PMID: 23581555 BACKGROUND

• Bennett SJ, Oldridge NB, Eckert GJ, Embree JL, Browning S, Hou N, Chui M, Deer M, Murray MD. Comparison of quality of life measures in heart failure. Nurs Res. 2003 Jul-Aug;52(4):207-16. doi: 10.1097/00006199-200307000-00001.

  PMID: 12867777 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion; Bronchiolitis Obliterans Syndrome; Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

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

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: October 4, 2018
• Study Start: October 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)