Pleural EffusionNCT03189654
Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
An observational study of Pleural Effusion and Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Heart Failure
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 12 Mar 2020
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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
Study population: Patients with decompensated heart failure and pleural effusion
Who may be able to join
- Patients admitted to our hospital on a routine or emergency basis
- Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
- Non-invasively determined cardiac index of < 2.5 l/min/m²
- BNP > 300 pg/ml
- Transudative pleural effusion according to Light criteria
- Effective pleurocentesis with residual effusion on the side affected of < 500 ml
- Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation
- No change in drug or other therapy for the duration of the study (5 days)
Who cannot join
- Psychological or neurological concomitant disease making an informed consent impossible
- Pregnancy
- Pneumothorax or pneumomediastinum
- Pathologically low blood pressure, particularly associated with intravascular volume depletion
- Liquor discharge, recent head surgery or trauma
- Severe bullous lung disease
Show all 10Show fewer
- Dehydration
- Current ventilation therapy
- Bilateral pleural effusion > 500 ml at the time of enrolment
- Exudative pleural effusion
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Bad Oeynhausen, 32545
About this study
There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement.
The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.
- Conditions
- Pleural Effusion, Heart Failure
- Being tested
- Non-invasive ventilation
- Medical subject headings
- Pleural Effusion, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Non-invasive ventilation after pleurocentesis Receives: Device: Non-invasive ventilation | |
| Control group | Oxygen Administration via nasal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of pleural effusion
Measured: 5 days
Secondary outcomes (3)
nt-Pro-BNP
Measured: 5 days
Cardiac output
Measured: 5 days
NYHA class
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2019
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed GmbH & Co KG
- Responsible party
- Principal investigator, Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Thomas Bitter, MD, Principal investigator, Heart and Diabetes Center North Rhine-Westphalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189654
- Sponsor's protocol ID
- HDZNRW-KA_010_TB
- Status last verified
- Jul 2020
- First submitted
- 14 Jun 2017
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03189654
- Acronym / sponsor ID
- HDZNRW-KA_010_TB
- Conditions
- Pleural Effusion, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Collaborators
- ResMed GmbH & Co KG
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 16 Jun 2017 (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.
There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement.
The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Device: Non-invasive ventilationNon-invasive ventilation after pleurocentesis |
| Control group | – | –Oxygen Administration via nasal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with decompensated heart failure and pleural effusion
Key inclusion criteria (8 listed)
- Patients admitted to our hospital on a routine or emergency basis
- Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
- Non-invasively determined cardiac index of < 2.5 l/min/m²
- BNP > 300 pg/ml
- Transudative pleural effusion according to Light criteria
Key exclusion criteria (10 listed)
- Psychological or neurological concomitant disease making an informed consent impossible
- Pregnancy
- Pneumothorax or pneumomediastinum
- Pathologically low blood pressure, particularly associated with intravascular volume depletion
- Liquor discharge, recent head surgery or trauma
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 |
|---|---|---|
| Non-invasive ventilationNon-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis | Device | Treatment group |
Primary outcome
Amount of pleural effusion
Time frame: 5 days
3 secondary outcomes
nt-Pro-BNP
Time frame: 5 days
Cardiac output
Time frame: 5 days
NYHA class
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- 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.
Thomas Bitter, MD principal investigator
Heart and Diabetes Center North Rhine-Westphalia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 30 Jul 2020. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of pleural effusion (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2020.