Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure (CHF)

Treatments: Drug: RLX030; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01546532

CRLX030A2202

2011-001588-37 (EudraCT Number)

Details and patient eligibility

About

This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Male and female heart failure patients with body weight <160 kg, on standard therapy including a stable dose of furosemide 40-240 mg/day orally (p.o). or equivalent dose of loop diuretics, reduced systolic function (LVEF ≤ 45% measured within the past 6 months), BNP ≥ 100 pg/mL or NT-pro-BNP of ≥ 400 pg/mLNYHA Class II or III, and worsening symptoms, e.g. fatigue, dyspnea, breathlessness within 3 months
• Mild to moderate renal impairment

Exclusion criteria

• Systolic blood pressure (SBP) < 110 mm Hg at the time of randomization
• Administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization
• Current use of non-steroidal antiinflammatory drugs (NSAIDs)
• Current or planned (through the completion of study drug infusion) treatment with any i.v. therapies, including vasodilators (including nesiritide), positive inotropic agents, vasopressors, levosimendan, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device).
• Clinically significant hepatic 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)

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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118 participants in 2 patient groups, including a placebo group

RLX030

Experimental group

Description:

RLX030 as intravenous infusion for 24 hours.

Treatment:

Drug: RLX030

Placebo

Placebo Comparator group

Description:

Placebo as intravenous infusion for 24 hours.

Treatment:

Drug: Placebo