Heart Failure
Conditions
Keywords
Biventriular chronic heart failure, Pulmonary hypertension
Brief summary
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.
Interventions
DRUGBAY60-4552
Single dose escalation planned at dose of 1 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters
Exclusion criteria
* Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pulmonary capillary wedge pressure | Pre-dose and up to 6 hr post-dose | — |
| Change in mean pulmonary artery pressure | Pre-dose and up to 6 hr post-dose | — |
| AUC | Pre-dose and up to 72 hr post-dose | Area under the plasma concentration vs time curve from zero to infinity after single dose |
| AUC/D | Pre-dose and up to 72 hr post-dose | AUC divided by dose (mg) |
| Cmax | Pre-dose and up to 72 hr post-dose | Maximum drug concentration in plasma after single dose administration |
| Cmax/D | Pre-dose and up to 72 hr post-dose | Cmax divided by dose (mg) |
| Number of participants with adverse events | Approximately 2 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic vascular resistance | Pre-dose and up to 6 hr post-dose | — |
| Systemic vascular resistance index | Pre-dose and up to 6 hr post-dose | — |
| Cardiac index | Pre-dose and up to 6 hr post-dose | — |
| Mean arterial pressure | Pre-dose and up to 6 hr post-dose | — |
| Systemic blood pressure | At pre-study visit, pre-dose and up to 24 hr post-dose | — |
| Diastolic blood pressure | At pre-study visit, pre-dose and up to 24 hr post-dose | — |
| Dyspnea Score | Pre-dose and up to 48 hr post-dose | Subject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale. |
| AUC(0-6) | Pre-dose and up to 6 hr post-dose | AUC from time 0 to 6 h after study drug intake |
| AUCnorm | Pre-dose and up to 72 hr post-dose | AUC divided by dose (mg) per kg body weight |
| AUC(0-tn) | Pre-dose and up to 72 hr post-dose | AUC from time 0 to the last data point |
| AUC(0-tn)norm | Pre-dose and up to 72 hr post-dose | AUC(0-tn) divided by dose (mg) per kg body weight |
| Cmax,norm | Pre-dose and up to 72 hr post-dose | Cmax divided by dose (mg) per kg body weight |
| tmax | Pre-dose and up to 72 hr post-dose | Time to reach maximum drug concentration in plasma after single dose |
| t½ | Pre-dose and up to 72 hr post-dose | Half-life associated with the terminal slope |
| Mean residence time | Pre-dose and up to 72 hr post-dose | — |
| Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) | Pre-dose and up to 72 hr post-dose | — |
| Apparent volume of distribution associated with the terminal phase (after oral administration) | Pre-dose and up to 72 hr post-dose | — |
| Amount of drug excreted via urine | Pre-dose and up to 6 hr post-dose | — |
| Percent amount of drug excreted via urine | Pre-dose and up to 6 hr post-dose | — |
| Mean right atrial pressure | Pre-dose and up to 6 hr post-dose | — |
| Renin activity | Pre-dose and up to 24 hr post-dose | — |
| Change from baseline of noradrenaline after drug administration | Pre-dose and up to 24 hr post-dose | — |
| N-terminal pro-atrial natriuretic peptide | Pre-dose and up to 24 hr post-dose | — |
| NT-pro B-type natriuretic peptide | Pre-dose and up to 24 hr post-dose | — |
| Big endothelin-1 | Pre-dose and up to 24 hr post-dose | — |
| Cystatin C | Pre-dose and up to 24 hr post-dose | — |
| Change from baseline of osteopontin after drug administration | Pre-dose and up to 24 hr post-dose | — |
| Cyclic guanosine mono-phosphate | Pre-dose and up to 24 hr post-dose | — |
| Renal clearance of drug | Pre-dose and up to 6 hr post-dose | — |
| Systolic pulmonary artery pressure | Pre-dose and up to 6 hr post-dose | — |
| Diastolic pulmonary artery pressure | Pre-dose and up to 6 hr post-dose | — |
| Heart rate | At pre-study visit, pre-dose and up to 24 hr post-dose | — |
| Cardiac output | Pre-dose and up to 6 hr post-dose | — |
| Pulmonary vascular resistance | Pre-dose and up to 6 hr post-dose | — |
| Pulmonary vascular resistance index | Pre-dose and up to 6 hr post-dose | — |
Countries
Germany
Outcome results
None listed