ClinicalTrials.gov
ClinicalTrials.gov Menu

Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03189654
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
ResMed GmbH & Co KG
Information provided by (Responsible Party):
Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia

Brief 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. 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.


Condition or disease Intervention/treatment
Pleural Effusion Heart Failure Device: Non-invasive ventilation

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Days
Official Title: Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Treatment group
Non-invasive ventilation after pleurocentesis
Device: Non-invasive ventilation
Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis

Control group
Oxygen Administration via nasal tube



Primary Outcome Measures :
  1. Amount of pleural effusion [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. nt-Pro-BNP [ Time Frame: 5 days ]
  2. Cardiac output [ Time Frame: 5 days ]
  3. NYHA class [ Time Frame: 5 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with decompensated heart failure and pleural effusion
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Dehydration
  • Current ventilation therapy
  • Bilateral pleural effusion > 500 ml at the time of enrolment
  • Exudative pleural effusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189654


Contacts
Contact: Marco Koester, MD 49 5731 ext 973335 mkoester@hdz-nrw.de
Contact: Astrid Kleemeyer 49 5731 ext 971258 akleemeyer@hdz-nrw.de

Locations
Germany
Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Astrid Kleemeyer    49 5731 97 ext 1258    akleemeyer@hdz-nrw.de   
Sub-Investigator: Marco Köster, MD         
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
ResMed GmbH & Co KG
Investigators
Principal Investigator: Thomas Bitter, MD Heart and Diabetes Center North Rhine-Westphalia

Responsible Party: Thomas Bitter, Senior physician, Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT03189654     History of Changes
Other Study ID Numbers: HDZNRW-KA_010_TB
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Pleural Effusion
Heart Diseases
Cardiovascular Diseases
Pleural Diseases
Respiratory Tract Diseases