NCT05017753Completed
Thoracentesis to Alleviate Cardiac Pleural Effusion
Thoracentesis to Alleviate Cardiac Pleural Effusion - an Interventional Trial (TAP-IT)
Source: ClinicalTrials.gov · Last updated 13 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 135 (actual)
- First submitted
- 12 Aug 2021
- Start date
- 31 Aug 2021
- Primary completion date
- 22 Mar 2024
- Lead sponsor
- Bispebjerg Hospital
- Diseases
- Heart failure
- NCT number
- NCT05017753
What you commit to
- Study type: Interventional
- Participants enrolled: 135
- From 31 Aug 2021 to the primary completion date, 22 Mar 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically indicated diagnostic thoracentesis (e.g. suspected malignant aetiology)
- Recent (\<3 months) intrathoracic procedure (including heart or lung surgery, transcatheter aortic valve implantation (TAVI) or thoracentesis)
- Planned or expected admission \> 10 days for other condition than heart failure
Lab values
- Suspected pulmonary or pleural infection (pneumonia symptoms with c- reactive protein\>100 mg/L or white blood count\>11)
- Contraindications to thoracentesis according to local guidelines (such as spontaneously elevated international normalized ratio (INR) or thrombocytopenia), patients on oral anticoagulation may be randomized.
- Estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2 or dialysis treatment
Other
- 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)
- Inability to give informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Aalborg Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| University Hospital Aarhus Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| University Hospital Bispebjerg and Frederiksberg Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| University Hospital, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| University Hospital Rigshospitalet, Glostrup Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| University Hospital Herlev/Gentofte Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| University Hospital Nordsjaelland Coordinator of this site? Confirm its status | Hillerød | Denmark | Unknown status |
| University Hospital Hvidovre Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
| University Hospital Odense Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| University Hospital Zealand, Roskilde Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.