Critically ill patients, male and female, admitted to hospital with decompensated chronic congestive heart failure and clinical indication for parenteral pharmacotherapy with invasive hemodynamic monitoring and a PCWP of higher or equal 18 mmHg.
Conditions
Interventions
Product Name: BAY 58-2667
Product Code: BAY 58-2667
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BAY 58-2667
Other descriptive name: 4-({(4-carboxybutyl)[2-(2-{[4-(2-phenylethyl) b
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Critically ill patients, male and female, admitted to hospital with decompensated chronic congestive heart failure and clinical indication for parenteral pharmacotherapy with invasive hemodynamic monitoring and a PCWP of higher or equal 18 mmHg. ? Male patients older than 18 years of age. ?Postmenopausal female patients older than 55 years or women without childbearing potential based on surgical treatment like bilateral tubal ligation, bilateral ovarectomy or hysterectomy. ? Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period. ?Subjects must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Women with childbearing potential; ? Heart Failure NYHA Class I + II; ? Acute heart failure; - RR < 100/60 mmHg - need for acute cardiologic intervention or surgery; - cardiogenic shock; - primary need for catecholamine; - need of invasive mechanical ventilation; ? Instable patient; ? Renal insufficiency creatinine 2 mg/dL = 177 µmol/L; ? Participation in another clinical trial during the preceding 3 months; ? Resting heart rate in the awake subject below 45 BPM or above 120 BPM; ? Relevant pathological changes in the ECG such as a second or third-degree AV block, ? Febrile illness within 1 week before the start of the study; ? Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies; ?A history of relevant diseases of the central nervous system or other organs; ? Subjects with a medical disorder, condition or history of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator or the sponsor; ? Subjects with hypersensitivity to the investigational drug, the control agent and/or to inactive constituents;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Secondary Objective: The secondary objective of part A is to investigate the safety, tolerability and pharmacokinetics of the respective dose levels. The secondary objective of part B is to investigate the safety, tolerability and pharmacokinetics and subjective effects on dyspnoea of the respective dose levels of BAY 58-2667. ;Main Objective: The primary objective of part A is to investigate the hemodynamic and subjective effects on dyspnoea and well-being of 3 doses of BAY 58-2667 given intravenously over 2 hours per dose step in a dose escalation manner. In total, 3 dose steps per subject are planned. The primary objective of part B is to investigate the hemodynamic effect of BAY 58-2667 given intravenously over 6 hours. | — |
Countries
Germany
Outcome results
None listed