Study Summary
This trial is studying whether a tunneled pleural catheter (TPC) can improve quality of life for people with congestive heart failure (CHF) who have recurrent symptomatic pleural effusions that are not helped by diuretics.
Eligible Conditions
- Congestive Heart Failure
- Shortness of Breath
- Chronic Pleural Effusions
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: 1 year post-enrollment
1 year post-enrollment
All cause mortality
Incidence of hemothorax
Incidence of hospitalizations and emergency room encounters
Incidence of pleural procedures
Incidence of pleural space or chest wall infection
Incidence of pleurodesis
Incidence of trapped lung, loculated pleural effusion, and pneumothorax
Rate of hemodialysis initiation
Time to pleurodesis among those who achieved pleurodesis
Month 12
Change from baseline serum albumin
Change from baseline serum creatinine
Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire
New York Heath Association (NYHA) functional class
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual Care
1 of 2
Intervention Group
1 of 2
Active Control
Experimental Treatment
210 Total Participants · 2 Treatment Groups
Primary Treatment: tunneled pleural catheter · No Placebo Group · N/A
Intervention Group
Device
Experimental Group · 1 Intervention: tunneled pleural catheter · Intervention Types: DeviceUsual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post-enrollment
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,411 Previous Clinical Trials
6,941,379 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have had two or more episodes of pleural effusions
The pleural fluid is clinically determined to be due only to CHF.
The patient has a documented subjective symptom relief after thoracentesis and drainage of the pleural space.
References
- Writing Group Members, Véronique L. Roger, Alan S. Go, Donald M. Lloyd-Jones, Emelia J. Benjamin, Jarett D. Berry, William B. Borden, et al.. 2012. “Heart Disease and Stroke Statistics—2012 Update”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0b013e31823ac046.
- Davies, Helen E., Eleanor K. Mishra, Brennan C. Kahan, John M. Wrightson, Andrew E. Stanton, Anur Guhan, Christopher W. H. Davies, et al.. 2012. “Effect of an Indwelling Pleural Catheter Vs Chest Tube and Talc Pleurodesis for Relieving Dyspnea in Patients with Malignant Pleural Effusion”. Jama. American Medical Association (AMA). doi:10.1001/jama.2012.5535.
- LIGHT, RICHARD W.. 1972. “Pleural Effusions: The Diagnostic Separation of Transudates and Exudates”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-77-4-507.
- Light, R.W.. 1997. “Diagnostic Principles in Pleural Disease”. European Respiratory Journal. European Respiratory Society (ERS). doi:10.1183/09031936.97.10020476.
- Krishnan, Mrinalini, Pramil Cheriyath, Yijin Wert, and Troy A. Moritz. 2015. “The Untapped Potential of Tunneled Pleural Catheters”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.05.086.
- Srour, Nadim, Rajini Potechin, and Kayvan Amjadi. 2013. “Use of Indwelling Pleural Catheters for Cardiogenic Pleural Effusions”. Chest. Elsevier BV. doi:10.1378/chest.13-0331.
- Chalhoub, Michel, Kassem Harris, Michael Castellano, Rabih Maroun, and Ghada Bourjeily. 2011. “The Use of the Pleurx Catheter in the Management of Non-malignant Pleural Effusions”. Chronic Respiratory Disease. SAGE Publications. doi:10.1177/1479972311407216.
- Majid, Adnan, Fayez Kheir, Meghan Fashjian, Sumit Chatterji, Sebastian Fernandez-Bussy, Sebastian Ochoa, George Cheng, and Erik Folch. 2016. “Tunneled Pleural Catheter Placement with and Without Talc Poudrage for Treatment of Pleural Effusions Due to Congestive Heart Failure”. Annals of the American Thoracic Society. American Thoracic Society. doi:10.1513/annalsats.201507-471bc.
- Romero-Candeira, Santiago, Cleofe Fernández, Concepción Martı́n, José Sánchez-Paya, and Luis Hernández. 2001. “Influence of Diuretics on the Concentration of Proteins and Other Components of Pleural Transudates in Patients with Heart Failure”. The American Journal of Medicine. Elsevier BV. doi:10.1016/s0002-9343(01)00726-4.
- Roth, Bernard J., Thomas F. O'Meara, and W. Hal Cragun. 1990. “The Serum-effusion Albumin Gradient in the Evaluation of Pleural Effusions”. Chest. Elsevier BV. doi:10.1378/chest.98.3.546.
- Kawano, Hiroaki, Shuji Arakawa, Osami Satoh, Yuji Matsumoto, Motonobu Hayano, Daisuke Nakatomi, Toshihiko Yamasa, and Koji Maemura. 2013. “Effect of Pimobendan in Addition to Standard Therapy for Heart Failure on Prevention of Readmission in Elderly Patients with Severe Chronic Heart Failure”. Geriatrics & Gerontology International. Wiley. doi:10.1111/ggi.12067.
- Light, Richard W.. 2002. “Pleural Effusion”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmcp010731.
- Chakko, Simon C., Stephen H. Caldwell, and Peter P. Sforza. 1989. “Treatment of Congestive Heart Failure”. Chest. Elsevier BV. doi:10.1378/chest.95.4.798.
- Freeman, Richard K., Anthony J. Ascioti, Megan Dake, and Raja S. Mahidhara. 2014. “A Propensity-matched Comparison of Pleurodesis or Tunneled Pleural Catheter for Heart Failure Patients with Recurrent Pleural Effusion”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2014.02.027.
- Roberts, M. E., E. Neville, R. G. Berrisford, G. Antunes, N. J. Ali, and on behalf of the BTS Pleural Disease Guideline Group. 2010. “Management of a Malignant Pleural Effusion: British Thoracic Society Pleural Disease Guideline 2010”. Thorax. BMJ. doi:10.1136/thx.2010.136994.
- Race, George A., Charles H. Scheifley, and Jesse E. Edwards. 1957. “Hydrothorax in Congestive Heart Failure”. The American Journal of Medicine. Elsevier BV. doi:10.1016/0002-9343(57)90339-x.
- Bottle, Alex, Rosalind Goudie, Derek Bell, Paul Aylin, and Martin R Cowie. 2016. “Use of Hospital Services by Age and Comorbidity After an Index Heart Failure Admission in England: An Observational Study”. BMJ Open. BMJ. doi:10.1136/bmjopen-2015-010669.
- Bennett, Susan J., Neil B. Oldridge, George J. Eckert, Jennifer L. Embree, Sherry Browning, Nan Hou, Michelle Chui, Melissa Deer, and Michael D. Murray. 2003. “Comparison of Quality of Life Measures in Heart Failure”. Nursing Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00006199-200307000-00001.
- Light, R.W.. 1997. “Diagnostic Principles in Pleural Disease”. European Respiratory Journal. European Respiratory Society (ERS). doi:10.1183/09031936.97.10020476.
- 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.
- Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
- 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.
- Scott S. Oh, DO, FCCP, DAABIP 2020. "Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03696524.
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