Pleural Effusions, ChronicTREAT-CHFNCT03696524
Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial
A study testing tunneled pleural catheter in people with Pleural Effusions, Chronic and Congestive Heart Failure, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusions, Chronic, Congestive Heart Failure, Shortness of Breath
- What is being tested?
- tunneled pleural catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- On hemodialysis during enrollment
- Exudative pleural effusion, defined as any effusion that dose not meet criteria for transudate or pseudoexudate
- Contraindication for TPC insertion
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- tunneled pleural catheter
- Keywords
- congestive heart failure, pleural effusion, shortness of breath, tunneled pleural catheter, thoracentesis
- Medical subject headings
- Pleural Effusion, Bronchiolitis Obliterans Syndrome, Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunneled pleural catheterDevice
Also called pleurx catheter placement
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year post-enrollment
Secondary outcomes (11)
All cause mortality
All cause mortality
Measured: 1 year post-enrollment
New York Heath Association (NYHA) functional class
NYHA functional class: I, III, III, or IV
Measured: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
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.
Measured: 1 year post-enrollment
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.
Measured: 1 year post-enrollment
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.
Measured: 1 year post-enrollment
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.
Measured: 1 year post-enrollment
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.
Measured: 1 year post-enrollment
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.
Measured: 1 year post-enrollment
Change from baseline serum albumin
serum albumin levels
Measured: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Change from baseline serum creatinine
serum creatinine levels
Measured: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Rate of hemodialysis initiation
We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis
Measured: 1 year post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Oct 2020
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusions, ChronicStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be an intervention group (receiving the tunneled pleural catheter) and a usual care group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott S. Oh, DO, FCCP, DAABIP, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696524
- Sponsor's protocol ID
- 18-000400
- Acronym
- TREAT-CHF
- Status last verified
- Apr 2023
- First submitted
- 11 Sep 2018
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24726601Roberts 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.
PubMed 20696691Light 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.
PubMed 4642731Davies 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.
PubMed 22610520Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
PubMed 12075059Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
PubMed 16623208EDWARDS 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.
PubMed 13381740Roger 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.
PubMed 22179539Majid 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.
PubMed 26598967Krishnan 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.
PubMed 26294344Srour 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.
PubMed 23807028Chalhoub 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.
PubMed 21636653Chakko 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.
PubMed 2924609Romero-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.
PubMed 11403751Roth 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.
PubMed 2152757
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial
- ClinicalTrials.gov ID
- NCT03696524
- Acronym / sponsor ID
- TREAT-CHF / 18-000400
- Keywords
- congestive heart failure, pleural effusion, shortness of breath, tunneled pleural catheter, thoracentesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be an intervention group (receiving the tunneled pleural catheter) and a usual care group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: tunneled pleural catheterThis 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. |
| Usual Care | No intervention | –The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Imminent death within 1 month
- Heart transplant candidate
- Lone right sided heart failure with normal left sided cardiac function
- Active malignancy
- Active pulmonary infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tunneled pleural catheterAlso: pleurx catheter placementPlacement 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. | Device | Intervention Group |
Primary outcome
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
11 secondary outcomes
All cause mortality
Time frame: 1 year post-enrollment
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)
Incidence of pleural procedures
Time frame: 1 year post-enrollment
Incidence of pleural space or chest wall infection
Time frame: 1 year post-enrollment
Incidence of hemothorax
Time frame: 1 year post-enrollment
Incidence of trapped lung, loculated pleural effusion, and pneumothorax
Time frame: 1 year post-enrollment
Incidence of pleurodesis
Time frame: 1 year post-enrollment
Time to pleurodesis among those who achieved pleurodesis
Time frame: 1 year post-enrollment
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)
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)
Rate of hemodialysis initiation
Time frame: 1 year post-enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 24726601Freeman 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.
- Background: PubMed 20696691Roberts 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.
- Background: PubMed 4642731Light 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.
- Background: PubMed 22610520Davies 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.
- Background: PubMed 12075059Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
- Background: PubMed 16623208Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
- Background: PubMed 13381740EDWARDS 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.
- Background: PubMed 22179539Roger 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.
- Background: PubMed 26598967Majid 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.
- Background: PubMed 26294344Krishnan 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.
- Background: PubMed 23807028Srour 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.
- Background: PubMed 21636653Chalhoub 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tunneled pleural catheter in people with Pleural Effusions, Chronic and Congestive Heart Failure, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696524, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.