Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Novartis

Status and phase: Completed; Phase 2

Conditions: Acute Heart Failure

Treatments: Drug: RLX030; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01543854

CRLX030A2201

2011-000833-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 87 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

RLX030

Experimental group

Description:

RLX030 as intravenous infusion for 20 hours

Treatment:

Drug: RLX030

Placebo

Placebo Comparator group

Description:

Matching placebo as intravenous infusion for 20 hours.

Treatment:

Drug: Placebo