Proof of concept study to investigate the impact of BAY 58-2667 given intravenously in patients with acute decompensated chronic congestive heart failure

• Conditions: 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.

• Registration Number: EUCTR2005-004473-14-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-28
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

? 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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified