EUCTR2007-003059-36-SIActive, not recruitingPhase 1
Placebo controlled, randomized, double-blind, multi-center, multinational Phase IIb study to investigate the efficacy and tolerability of BAY 58-2667 given intravenously in patients with acute decompensated chronic congestive heart failure
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer Healthcare AG
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •The following inclusion criteria must be met:
- •Patients with acute 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 mmgHg.
- •Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
- •Male or female patients, aged 18 years or more. Female patients should be postmenopausal for at least one year.
- •Patients must experience worsening of at least one of the symptoms below leading to hospitalization at the time of entry into the study:
- •Dyspnea Symptoms such as:
- •Dyspnea (labored or difficult breathing) at rest,
- •Dyspnea (labored or difficult breathing) on minimal exertion
- •Orthopnea (difficult breathing except in the upright position),
- •Nocturnal dyspnea (awaken from sleep due to respiratory distress).
- •Clinical evidence of volume overload such as:
- •peripheral edema,
- •hepatic congestion with ascites,
- •pulmonary congestion/rales, or pleural effusion (chest X-ray)
- •jugular venous distension.
- •Left ventricular ejection fraction < 40 % within the last 6 months.
- •Ability to understand and willing to sign informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •The following factors determined during the run-in period will automatically exclude the subject from participating in the trial:
- •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.
- •Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease.
- •Primary hypertrophic cardiomyopathy.
- •Acute inflammatory heart disease, e.g. acute myocarditis.
- •Unstable angina requiring angiography
- •Cardiogenic shock
- •Patients requiring any of the following: : nitrates,( e.g. nitroprusside, nitroglycerin); vasodilators (e.g. nesiritide), any intravenous positive inotropic drug (e.g. levosimendan) or vasoconstrictive agents (e.g. catecholamines) within the last 3 hours (dobutamine up to 4 µg/kg/minute is allowed).
- •Need for endotracheal intubation and mechanical ventilation.
- •Patients with cardiac arrest or patients with history of cardiac arrest within 3 months, unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, severe transient electrolyte abnormality, an electrophysiology procedure, or addressed by automatic implantable cardioverter defibrillator placement.
- •Patients with increased risk of cardiac arrest (e.g. AV Block °III, QTc > 450 msec for men and QTc > 470 msec for women if patient is in sinus rhythm and there is no conduction delay in the ECG influencing the QT-interval.)
- •Ventricular fibrillation within 30 days (> 15 seconds long)
- •Patients showing during ECG monitoring uncontrolled ventricular rhythm disorder.
- •Uncontrolled atrial fibrillation or flutter or any supraventricular tachycardia.
- •Cardiac surgery within the last month (such as cardiac revascularization surgery, valvular surgery, biventricular resynchronization procedure, ventricular reduction surgery or cardiac myoplasty, implantation of mechanical ventricular assist device).
- •Systolic blood pressure < 100 mmHg or > 180 mmHg.
- •Heart rate = 120 BPM
- •Pulmonary embolism within the last 30 days prior to enrollment.
- •PDE 5 inhibitor use within the last 48 hours.
- •Strong CYP2C8 (inhibitors like gemfibrozil(stop at least 24 hours before study drug infusion)
- •Heart failure secondary to pulmonary disease and patients with primary pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
- •History of or clinically significant evidence of any severe disease other than heart failure that preclude participation.
- •Known significant liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis).
- •Calculated creatinine clearance < 30 mL/min. using MDRD or Cockroft Gault equation
- •BMI < 20 kg/m2 (BMI equal to 20 is accepted)
- •Drug- or alcohol abuse.
- •Concomitant participation in another trial or study.
- •Therapy with ano
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