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

A Double-blind, Placebo-controlled, Randomized Trial Investigating the Safety and Efficacy of Additive Renin Inhibition With Aliskiren on Renal Blood Flow and Neurohormonal Activation in Patients With Chronic Heart Failure and Renal Dysfunction

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881439

Acronym

ARIANA-CHF-RD

Enrollment

Registered

2009-04-15

Start date

2009-04-30

Completion date

2012-12-31

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Kidney Failure

Keywords

Heart failure, Renal Failure, Cardiorenal Syndrome, Renin inhibition, Aliskiren

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.

Interventions

DRUGAliskiren

Oral, 300 mg, once daily, 6 months

DRUGPlacebo

Matching Placebo once daily, 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate	6 months
Change in systolic and diastolic blood pressure	6 months
change in N-terminal pro brain natriuretic peptide levels (NT-proBNP)	6 months
Change in left ventricular ejection fraction	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026