Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire
时间窗: 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
时间窗: 1 year post-enrollment
Measurement of all significant health care visits, including hospitalizations and emergency room encounters
次要结局
- Incidence of pleural procedures(1 year post-enrollment)
- Incidence of pleural space or chest wall infection(1 year post-enrollment)
- Change from baseline serum creatinine(Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months))
- Incidence of hemothorax(1 year post-enrollment)
- Incidence of trapped lung, loculated pleural effusion, and pneumothorax(1 year post-enrollment)
- Rate of hemodialysis initiation(1 year post-enrollment)
- Time to pleurodesis among those who achieved pleurodesis(1 year post-enrollment)
- Change from baseline serum albumin(Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months))
- 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))
- All cause mortality(1 year post-enrollment)
- Incidence of pleurodesis(1 year post-enrollment)
研究者
Scott S. Oh, DO, FCCP, DAABIP
Associate Professor of Medicine
University of California, Los Angeles