EUCTR2011-000833-35-PL
Active, not recruiting
Not Applicable
A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 70
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\- Patients admitted to hospital or who require admission to hospital for management of acute heart failure with shortness of breath at rest or minimal exertion
- •\- stabilized within 2 days after admission
- •\- normal or elevated systolic blood pressure
- •\- elevated pulmonary capilary wedge pressure measured by Swan\-Ganz catheterization
- •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 30
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 35
Exclusion Criteria
- •\- severe renal impairment
- •\- significant liver impairment defined as hepatic encephalopathy of any degree or total bilirubin \> 50 µmol/l (3 mg/dl) or, if patient is not on warfarin therapy, INR \> 2\.0 (or Prothrombin Time \> 2 \* ULN)
- •\- significant lung impairment
- •\- significant heart valve dysfunction or arrythmias
- •\- myocardial infarction or acute coronary syndrome within th elast 45 days
Investigators
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