Hemodynamic responses to intravenous RLX030 infusion in patients with acute heart failure
- Conditions
- Acute Heart FailureMedDRA version: 14.1Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000833-35-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method