Trial Condition(s):
Single dose escalation study in patients with chronic heart failure
This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.
- Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters
- Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease
Locations | Status | ||
---|---|---|---|
Locations Investigative Site Gießen, Germany, 35392 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bad Nauheim, Germany, 61231 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Proof of concept study to investigate safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics of a single oral dose of BAY60-4552 in patients with biventricular chronic heart failure and pulmonary hypertension in a non-randomized, non-blinded, dose escalation design.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
5