check_circleStudy Completed

Heart Failure

Bayer Identifier:

11615

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2005-004473-14

EU CT Number:

Not Available
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
  • - Critically ill subjects
    - Male (older than 18 years ) and female (older than 55 years)
    - Admitted to hospital with decompensated chronic CHF and clinical indication for parenteral pharmacotherapy with invasive hemodynamic monitoring and a pulmonary capillary wedge pressure of ≥18 mmHg
    - Postmenopausal female subjects or women without child bearing potential based on surgical treatment like bilateral tubal ligation, bilateral ovariectomy, or hysterectomy
  • - Women with childbearing potential;
    - Heart failure NYHA Class I and II
    - Acute heart failure (blood pressure <100 mmHg systolic or <60 mmHg diastolic, need for acute cardiological intervention or surgery, cardiogenic shock, primary need for catecholamines, need for invasive mechanical ventilation)
    - Unstable subjects
    - Subjects with acute coronary syndrome;
    - Renal insufficiency with serum 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
    - Medical disorders, condition or history that would impair the subject’s ability to participate or complete this study including the history of relevant diseases of vital organs, of the central nervous system; and 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 or with hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents

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

Additional Information

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