Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment

Phase 2

Terminated

• Conditions: Heart Failure; Kidney Failure
• Interventions: Drug: Placebo; Drug: Aliskiren

• Registration Number: NCT00881439
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function.

* Primary outcome measure: change in renal blood flow at 6 months

* Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones

Detailed Description

This study is a randomized, double-blind, placebo controlled, parallel group comparison trial, enrolling 100 patients (67 vs. 33) with stable CHF. Patients will be randomized to Aliskiren 300 mg once daily or corresponding Placebo for a period of 6 months. Efficacy measures will be performed at baseline and at the end of the study. Primary efficacy outcome is change in renal blood flow as measured by 131I-Hippuran clearance. Secondary outcome include change in renal function, neurohormones, left ventricular function and blood pressure. Safety assessments include renal function, changes in electrolytes, and blood pressure. Patients will be uptitrated to maximum tolerated doses of Aliskiren, and safety visits are planned 1 week after initiation and on a 2 month interval afterwards. A total of 8 visits are planned during the entire study period.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• NYHA II-IV Heart Failure
• Left ventricular ejection fraction < 45%
• Stable heart failure medication
• eGFR by sMDRD formula between 30 and 60 mL/min/1.73m2

Exclusion Criteria

• Known hypersensitivity to study drug or ACEi
• Concomitant treatment with both ARB and Aldosterone Receptor Antagonist
• Symptomatic Hypotension
• Acute Heart Failure
• History of stroke, acute coronary syndrome, PCI or angioplasty within past 3 months
• Serum potassium > 5.2 mmol/L
• Right heart failure due to severe pulmonary disease
• Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Aliskiren	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
Change in renal blood flow as assessed by 131I-Hippuran clearance	6 months

Secondary Outcome Measures

Name	Time	Method
change in N-terminal pro brain natriuretic peptide levels (NT-proBNP)	6 months
Change in left ventricular ejection fraction	6 months
change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate	6 months
Change in systolic and diastolic blood pressure	6 months
change in NYHA class, change in filtration fraction, change in albumin excretion, change in tubular function parameters, change in neurohormonal activation	6 months

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands