A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Infusion of 150 µg/h during 48h.
Infusion of 100 µg/h during 48h
Infusion of 50 µg/h during 48h
Dyspnea VAS (using a visual analogue scale)
Time frame: 8 hours
Dyspnea assessment (Likert Scale)
Time frame: up to follow-up (30 - 35 days)
Overall health status assessment (EQ-5D)
Time frame: up to follow-up (30 - 35 days)
Changes in the dyspnea VAS at other time points
Time frame: Up to follow up visit
Dyspnea assessment through Likert scale
Time frame: Up to follow up visit
Overall health status assessment through EQ-5D Health Questionnaire
Time frame: Up to the follow-up visit
Global clinical assessment by the physician
Time frame: At 8, 24, and 48 hours
Change in concomitant medications
Time frame: During the treatment
Safety variables
Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment
Time frame: Up to end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Infusion during 48h
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Québec, Quebec, Canada
Unnamed facility
Brno, Czechia
...and 60 more locations