Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667
- Conditions
- Congestive Heart Failure
- Interventions
- Drug: Placebo
- Registration Number
- NCT00559650
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
- Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg.
- Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
- Male or female patients, age 18 years or more.
- Females of child-bearing potential.
- Acute de-novo heart failure.
- Acute myocardial infarction and/or myocardial infarction within 30 days.
- Valvular heart disease requiring surgical intervention during the course of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Placebo - Arm 2 Cinaciguat (BAY58-2667) -
- Primary Outcome Measures
Name Time Method The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo. 8 hours
- Secondary Outcome Measures
Name Time Method Quality of Life Up to 30 days Follow-up Other hemodynamic measurements Up to 48 hours Right atrial pressure (RAP); mean pulmonary artery pressure (PAP mean); pulmonary artery systolic pressure (PASP); pulmonary artery diastolic pressure (PADP); cardiac output (CO); cardiac index (CI); mean arterial pressure (MAP); pulmonary vascular resistance (PVR); pulmonary vascular resistance index (PVRI); systemic vascular resistance (SVR); and systemic vascular resistance index (SVRI）
Rehospitalization Up to 30 days Follow-up Safety variables Up to 30 days follow up Treatment-emergent adverse events, laboratory parameters, renal function, in-hospital mortality, length of stay at intensive care unit, and 30-day mortality / morbidity.
Plasma concentrations During both the titration and maintenance phases were evaluated.