Overview

Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure. In addition safety and effects on renal function and biomarkers will be assessed.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
Inclusion Criteria:

- Patients hospitalized or requiring admission to hospital for management of acute heart
failure within the previous 48 hours.

- Pulmonary wedge pressure above or equal to18 mmHg determined by right heart
catheterization

Exclusion Criteria:

- Systolic blood pressure below 115 mmHg

- Significant valvular diseases or arrythmias

- Acute coronary syndrome in previous 45 days

- Treatment with mechanical support (intra-aortic balloon pump, endotracheal intubation,
mechanical ventilation, or any ventricular assist device)

- Impaired renal or hepatic function

Other protocol-defined inclusion/exclusion criteria may apply