Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment (ARIANA-CHF-RD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881439
Recruitment Status : Terminated (Futility)
First Posted : April 15, 2009
Last Update Posted : May 17, 2013
Information provided by (Responsible Party):
H.L. Hillege, 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

Condition or disease Intervention/treatment Phase
Heart Failure Kidney Failure Drug: Aliskiren Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Aliskiren
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Matching Placebo once daily, 6 months
Active Comparator: Aliskiren Drug: Aliskiren
Oral, 300 mg, once daily, 6 months
Other Names:
  • Rasilez
  • SPP100

Primary Outcome Measures :
  1. Change in renal blood flow as assessed by 131I-Hippuran clearance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate [ Time Frame: 6 months ]
  2. Change in systolic and diastolic blood pressure [ Time Frame: 6 months ]
  3. change in N-terminal pro brain natriuretic peptide levels (NT-proBNP) [ Time Frame: 6 months ]
  4. Change in left ventricular ejection fraction [ Time Frame: 6 months ]
  5. change in NYHA class, change in filtration fraction, change in albumin excretion, change in tubular function parameters, change in neurohormonal activation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00881439

University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
University Medical Center Groningen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: H.L. Hillege, Prof.dr., University Medical Center Groningen Identifier: NCT00881439     History of Changes
Other Study ID Numbers: ARIANA
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by H.L. Hillege, University Medical Center Groningen:
Heart failure
Renal Failure
Cardiorenal Syndrome
Renin inhibition

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases