Thoracentesis to Alleviate Cardiac Pleural Effusion
Denmark135 participantsStarted 2021-08-31
Plain-language summary
The present study will examine the comparative effectiveness of two treatment strategies currently used in the treatment of patients with systolic heart failure presenting with pleural effusion. Patients will be randomized to standard medical treatment only or medical treatment and referral to thoracentesis.
Study hypothesis: A strategy of referring patients with heart failure-related pleural effusion to thoracentesis increases number of days alive outside of hospital over the following 90 days.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Left ventricular ejection fraction (LVEF) ≤ 45%
* Non- negligible pleural effusion by x-ray, ultrasound, CT or MRI, suspected to be due to heart failure
* Age ≥ 18 years
Exclusion Criteria:
* Clinically indicated diagnostic thoracentesis (e.g. suspected malignant aetiology)
* Suspected pulmonary or pleural infection (pneumonia symptoms with c- reactive protein\>100 mg/L or white blood count\>11)
* Recent (\<3 months) intrathoracic procedure (including heart or lung surgery, transcatheter aortic valve implantation (TAVI) or thoracentesis)
* Contraindications to thoracentesis according to local guidelines (such as spontaneously elevated international normalized ratio (INR) or thrombocytopenia), patients on oral anticoagulation may be randomized.
* Severe aortic stenosis
* Massive pleural effusion (equivalent to \>2/3 of lung on a standing chest x-ray)
* Substantially affected hemodynamics (systolic blood pressure \< 85mmHg, need of inotropes) or high oxygen demand (\>7L/min)
* Estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2 or dialysis treatment
* Planned or expected admission \> 10 days for other condition than heart failure
* Inability to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.