Decompensated Heartfailure Clinical Trial
Official 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?
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02993601 -
Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
|