check_circleStudy Completed

Heart Failure

BAY58-2667, iv dose titration over 6h infusion in patients

Trial purpose

Primary objective:
Part A: To investigate the hemodynamic and subjective effects on dyspnea as well as well-being of the subjects following 3 intravenous (IV) doses of BAY 58-2667 given over 2 h per dose step in a dose escalation manner.
Part B: To investigate the hemodynamic effects of BAY 58-2667 given IV over 6 h.

Secondary objectives:
Part A: To investigate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of the respective dose levels.
Part B: To investigate the safety, tolerability, PD, PK, and subjective effects on dyspnea of the respective dose levels of BAY 58-2667.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
60
Trial Dates
May 2006 - May 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
HELIOS Klinikum Erfurt GmbHErfurt, 99089, Germany
Completed
St.-Johannes-Hospital DortmundDortmund, 44137, Germany
Completed
Evangelisches und Johanniter KlinikumDuisburg, 47137, Germany
Completed
Heliols Klinikum WuppertalWuppertal, 42117, Germany
Completed
Schüchtermann Klinik Herzzentrum Osnabrück/Bad RothenfeldeBad Rothenfelde, 49214, Germany
Completed
Kerckhoff-Klinik GmbHBad Nauheim, 61231, Germany
Completed
Med. Fakultät der Martin-Luther-Universität Halle-WittenbergHalle, 06120, Germany
Terminated
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany

Primary Outcome

  • Pulmonary capillary wedge pressure
    date_rangeTime Frame:
    Upto 8 h after start of infusion
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    Safety Issue:
    No
  • Drug concentration in plasma
    date_rangeTime Frame:
    2, 4, and 6 h after start of infusion
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    Safety Issue:
    No
  • AUC 0-2, 2-4, 4-6
    Area under curve (AUC) from time 0-2 h, 2-4 h, and 4-6 h after start of infusion
    date_rangeTime Frame:
    0-2 h, 2-4 h, and 4-6 h after start of infusion
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    Safety Issue:
    No
  • AUC 0-2/D, AUC 2-4/D, and AUC 4-6/D
    AUC 0-2, AUC 2-4, and AUC 4-6 divided by dose
    date_rangeTime Frame:
    0-2 h, 2-4 h, and 4-6 h after start of infusion, respectively
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    Safety Issue:
    No

Secondary Outcome

  • Hemodynamic measurements
    Swan-Ganz hemodynamics [Measured: Mean right atrial pressure, mean pulmonary artery pressure, HR, cardiac output, systemic blood pressure. Calculated: Pulmonary vascular resistance, pulmonary vascular resistance index, systemic vascular resistance, systemic vascular resistance index, cardiac index] Impedance cardiography [stroke volume, cardiac output, heart rate, cardiac index]
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Subjective dyspnea and well being score
    Subjective dyspnea was measured using a 7-point Likert Scale
    date_rangeTime Frame:
    0, 2, 4, 6, 8, and 24 h after start of infusion
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    Safety Issue:
    No
  • AUC
    Area under the plasma concentration vs time curve from zero to infinity after single dose
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • AUCnorm
    AUC divided by dose per kg body weight
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • AUC(0-tn)
    AUC from time 0 to the last data point
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Cmax
    Maximum drug concentration in plasma after single dose
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Cmax,norm
    Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • MRT
    Mean residence time after an IV
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Biochemical parameters
    Noradrenaline, adrenaline, N-terminal atrial natriuretic peptide , N-terminal B-type natriuretic peptide, cyclic guanosine monophosphate (cGMP), and plasma renin activity (PRA) were determined in plasma
    date_rangeTime Frame:
    Up to 24 h after start of infusion
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    Safety Issue:
    No
  • tmax
    Time to reach maximum drug concentration in plasma after single dose
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • t1/2
    Half life associated with the terminal slope
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • CL
    Total body clearance of drug from plasma calculated after IV administration
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Vss
    Apparent volume of distribution at steady state
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Vz
    Apparent volume of distribution during terminal phase
    date_rangeTime Frame:
    Up to 8 h after start of infusion
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    Safety Issue:
    No
  • Functional classification according to NYHA (New York Heart Association)
    date_rangeTime Frame:
    Pre dose and up to 48 h after start of infusion
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    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 1 month after IV infusion
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    Safety Issue:
    Yes

Trial design

Proof of concept study to investigate the impact of BAY 58-2667 given intravenously in patients with acute decompensated chronic congestive heart failure
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3