Trial Condition(s):
Heart Failure
Single dose escalation study in patients with chronic heart failure
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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 |
Trial Design
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
Primary Outcome
- Change in pulmonary capillary wedge pressureTimeframe: Pre-dose and up to 6 hr post-dose
- Change in mean pulmonary artery pressureTimeframe: Pre-dose and up to 6 hr post-dose
- AUCArea under the plasma concentration vs time curve from zero to infinity after single doseTimeframe: Pre-dose and up to 72 hr post-dose
- AUC/DAUC divided by dose (mg)Timeframe: Pre-dose and up to 72 hr post-dose
- CmaxMaximum drug concentration in plasma after single dose administrationTimeframe: Pre-dose and up to 72 hr post-dose
- Cmax/DCmax divided by dose (mg)Timeframe: Pre-dose and up to 72 hr post-dose
- Number of participants with adverse eventsTimeframe: Approximately 2 weeks
Secondary Outcome
- Mean right atrial pressureTimeframe: Pre-dose and up to 6 hr post-dose
- Systolic pulmonary artery pressureTimeframe: Pre-dose and up to 6 hr post-dose
- Diastolic pulmonary artery pressureTimeframe: Pre-dose and up to 6 hr post-dose
- Heart rateTimeframe: At pre-study visit, pre-dose and up to 24 hr post-dose
- Cardiac outputTimeframe: Pre-dose and up to 6 hr post-dose
- Pulmonary vascular resistanceTimeframe: Pre-dose and up to 6 hr post-dose
- Pulmonary vascular resistance indexTimeframe: Pre-dose and up to 6 hr post-dose
- Systemic vascular resistanceTimeframe: Pre-dose and up to 6 hr post-dose
- Systemic vascular resistance indexTimeframe: Pre-dose and up to 6 hr post-dose
- Cardiac indexTimeframe: Pre-dose and up to 6 hr post-dose
- Mean arterial pressureTimeframe: Pre-dose and up to 6 hr post-dose
- Systemic blood pressureTimeframe: At pre-study visit, pre-dose and up to 24 hr post-dose
- Diastolic blood pressureTimeframe: At pre-study visit, pre-dose and up to 24 hr post-dose
- Dyspnea ScoreSubject is asked unpersuasively about his/her well-being in comparison to the baseline condition, measured on a 7-point Likert scale.Timeframe: Pre-dose and up to 48 hr post-dose
- AUC(0-6)AUC from time 0 to 6 h after study drug intakeTimeframe: Pre-dose and up to 6 hr post-dose
- AUCnormAUC divided by dose (mg) per kg body weightTimeframe: Pre-dose and up to 72 hr post-dose
- AUC(0-tn)AUC from time 0 to the last data pointTimeframe: Pre-dose and up to 72 hr post-dose
- AUC(0-tn)normAUC(0-tn) divided by dose (mg) per kg body weightTimeframe: Pre-dose and up to 72 hr post-dose
- Cmax,normCmax divided by dose (mg) per kg body weightTimeframe: Pre-dose and up to 72 hr post-dose
- tmaxTime to reach maximum drug concentration in plasma after single doseTimeframe: Pre-dose and up to 72 hr post-dose
- t½Half-life associated with the terminal slopeTimeframe: Pre-dose and up to 72 hr post-dose
- Mean residence timeTimeframe: Pre-dose and up to 72 hr post-dose
- Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: Pre-dose and up to 72 hr post-dose
- Apparent volume of distribution associated with the terminal phase (after oral administration)Timeframe: Pre-dose and up to 72 hr post-dose
- Amount of drug excreted via urineTimeframe: Pre-dose and up to 6 hr post-dose
- Percent amount of drug excreted via urineTimeframe: Pre-dose and up to 6 hr post-dose
- Renal clearance of drugTimeframe: Pre-dose and up to 6 hr post-dose
- Renin activityTimeframe: Pre-dose and up to 24 hr post-dose
- Change from baseline of noradrenaline after drug administrationTimeframe: Pre-dose and up to 24 hr post-dose
- N-terminal pro-atrial natriuretic peptideTimeframe: Pre-dose and up to 24 hr post-dose
- NT-pro B-type natriuretic peptideTimeframe: Pre-dose and up to 24 hr post-dose
- Big endothelin-1Timeframe: Pre-dose and up to 24 hr post-dose
- Cystatin CTimeframe: Pre-dose and up to 24 hr post-dose
- Change from baseline of osteopontin after drug administrationTimeframe: Pre-dose and up to 24 hr post-dose
- Cyclic guanosine mono-phosphateTimeframe: Pre-dose and up to 24 hr post-dose
Additional Information
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