Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005903

Trial Description

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Title

Does the Use of Optiflow High Flow Oxygen on Patients With Acute Cardial Decompensation (NYHA Classification Stage III-IV) Allow for Quicker Improvement of the Organ Dysfunction Than Conventional Standard-Oxygen-Insufflation-Therapy?

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The pilot study aims to compare the results of using a new respirator (OPTIFLOW
TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of
patients who have been hospitalized due to acute heart failure. We expect a faster and more
effective stabilization after acute cardial decompensation among the patients with the
High-Flow-machine.

The study should show whether the use of High-Flow-Therapy leads to a relevant improvement
in terms of objective clinical parameters of heart failure like those for cardial-renal
syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior
vena cava, in terms of the degree of shortness of breath and decompensation, and whether
subjective clinical symptoms like dyspnea and quality of life differ between the two groups
of patients.

The investigators see the primary outcome of the study as the improvement of the
cardial-renal syndrome as a sign of the more effective stabilisation compared to the
standard therapy. Furthermore, the investigators expect a quicker decrease in serum
creatinine and an improvement in the creatinine clearance through therapy with the
High-Flow-Machine. In terms of secondary outcomes of the study, the investigators are
interested in also comparing e.g., the duration of hospital stays, 90-day mortality, and
rehospitalisation within three months. Here, the investigators expect a quicker improvement
in the subjective shortness of breath of the patients who are treated using the
Hifh-Flow-Machine. Moreover, we believe that along with the individual subjective
improvements (quality of life survey), the patients will experience a quicker release from
the hospital and in this way, lead to a healthcare economic improvement among patients with
repeated hospitalizations who usually have chronic problems.

It is also of great interest to us, whether the biomarker BNP is an appropriate parameter
for determining the faster stabilization of the patient and whether the degree of
improvement of subjective dyspnea is correlated with the time needed until the patient has
been stabilised.

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Brief Summary in Scientific Language

Primary endpoint:

Improvement of the cardiorenal syndrome type1 measured by the improvement of creatine
clearance and the Serum-Creatinin of patients undergoing High-Flow treatment.

Secondary endpoints:

Worsening of cardiac insufficiency (application of catecholamines, need of NIV, intubation,
death) Duration of hospital stay (in days) 90-day mortality Readmittance to hospital within
3 months Intrathoracic bloodvolume at hospital discharge Change of dyspnea at 3h, 6h, 24h >
VAS-0-100 (visual analog scale) Change in the diameter of the IVC (inferior vena cava) as a
non-invasive parameter for assessing the degree of decompensation Change in the BNP
(hospital admission vs. discharge, after 3 months) Weight loss in hospital Amount of
diuretics

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Organizational Data

  •   DRKS00005903
  •   2015/02/26
  •   2014/02/06
  •   yes
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Secondary IDs

  •   NCT02058810  (ClinicalTrials.gov)
  •   300513  (University Hospital Regensburg)
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Health Condition or Problem studied

  •   Decompensated Heartfailure
  •   Cardio-renal Syndrom
  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Device: Nasal high flow
  •   Device: Conventional nasal oxygen
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Cardiorenal syndrome type 1; time frame: 3 Months; The acute deterioration of the cardial situation often leads to a consecutive deterioration of renal function. The damage to renal function caused by acute cardial genesis is defined as cardiorenal syndrome type 1 [2]. In such cases, the venous congestion with heightened central venous pressure leads to disruption of renalfunction and possibly even to acute kidney failure [3, 4]. This is defined as cardiorenal syndrom with an increase in serumcreatine of >0,3 mg/dl and is associated with higher mortality and longer hospital stays [5].

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Secondary Outcome

- Change of dyspnea; time frame: 3h, 6h, 24h; Change of dyspnea at 3h, 6h, 24h > VAS-0-100 (visual analog scale)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/09/30
  •   100
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- patients with acute heartfailure NYHA III und IV

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Exclusion Criteria

- Patients wit respiratory insufficency and indication for mechanical ventilation

- Asthma bronchiale

- severe COPD

- cardiogenic shock (RR persisting< 90mmHg systolic or catecholamine application)

- renal dialysis

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Addresses

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    • University Hospital Regensburg
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    • University of Magdeburg
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    • Maximilian V Malfertheiner, MD 
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    • Maximilian V Malfertheiner, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.