A randomized, subject and investigator-blind, placebo-controlled study of CLR325 in chronic stable heart failure patients.
- Conditions
- heart failure10019280
- Registration Number
- NL-OMON46128
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
- Written informed consent must be obtained before any assessment is performed;
- Able to communicate well with the investigator, to understand and comply with the requirements of the study;
- Male and female patients >18 years of age.
- Patients must weigh between 50kg and 140 kg to participate in the study;
- Patients with a cardiac ejection fraction of * 45% as assessed within the last 6 months;
- For PA catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization;
- In the opinion of the investigator, heart failure patients who will not require a change in their dose of ACE, ARB, *-blocker, mineralocorticoid receptor antagonist, or diuretic for 24 hours after randomization
- At baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least five minutes
- Presence of impaired renal function as indicated by clinically significant abnormal creatinine values (eGFR< 30 ml/min/1.73m2 calculated using the MDRD equation)
- Patients with values of AST or ALT>100 U/L measured within the last 3 months before randomization
- Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). positive Hepatitis B surface antigen (HBsAg) test excludes a patient. Patients with a positive Hepatitis C antibody test should have HCV RNA levels measured. Patients with positive (detectable) HCV RNA should be excluded.
- Patients with a history of chronic hepatitis of any non-cardiac etiology.
- History of any active, clinically significant cardiac tachyarrhythmia, such as recurrent atrial fibrillation with rapid ventricular response within the last year. Anticoagulation for patients with atrial fibrillation should be managed per usual clinical practice for patients undergoing right heart catheterization.
- Patients who have received an intravenous infusion of a cardiac inotrope (e.g.,dobutamine or milrinone) in the last 24 hours prior to randomization.
- For PA catheter cohorts, patients with a pulmonary capillary wedge pressure of >10 mm Hg at baseline.
- Patients with any significant change in their dose of their ACE, ARB, mineralocorticoid receptor antagonist, diuretic or *-blocker within the last 12 hours.
- Patients with minor changes in their heart failure regimen may be eligible if deemed clinically stable by both the investigator and sponsor.
- Patients with known significant valvular heart disease, as indicated by the following:
- Severe aortic stenosis (Aortic Valve Area >1.0 cm2 or peak gradient 50 mmHg as determined by echocardiography)
- Severe mitral stenosis
- Patients with history of acute coronary syndrome within the last 60 days as determined by both clinical and enzymatic criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the safety and tolerability of an 18-hour IV infusion of CLR325 in<br /><br>stable heart failure patients.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the pharmacokinetics of CLR325, and the active metabolite, CQJ295,<br /><br>during an 18-hour infusion of CLR325 in heart failure patients. To determine<br /><br>the immunogenicity of an 18-hour i.v. infusion of CLR325 in heart failure<br /><br>patients.</p><br>