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

Congestive Heart Failure Clinical Trial

— TREAT-CHF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03696524
• Other study ID #: 18-000400
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Dyspnea
• Heart Failure
• Pleural Effusion
• Pleural Effusions, Chronic
• Shortness of Breath

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

EDWARDS JE, RACE GA, SCHEIFLEY CH. Hydrothorax in congestive heart failure. Am J Med. 1957 Jan;22(1):83-9. doi: 10.1016/0002-9343(57)90339-x. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. Erratum In: Circulation. 2012 Jun 5;125(22):e1002. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	All cause mortality	All cause mortality	1 year post-enrollment
Secondary	New York Heath Association (NYHA) functional class	NYHA functional class: I, III, III, or IV	Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Secondary	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.	1 year post-enrollment
Secondary	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.	1 year post-enrollment
Secondary	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.	1 year post-enrollment
Secondary	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.	1 year post-enrollment
Secondary	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.	1 year post-enrollment
Secondary	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.	1 year post-enrollment
Secondary	Change from baseline serum albumin	serum albumin levels	Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Secondary	Change from baseline serum creatinine	serum creatinine levels	Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Secondary	Rate of hemodialysis initiation	We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis	1 year post-enrollment