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

This study has been terminated.

(Futility)

Sponsor:

Information provided by (Responsible Party):

H.L. Hillege, University Medical Centre Groningen

ClinicalTrials.gov Identifier:

NCT00881439

First received: April 14, 2009

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 14, 2009
Last Updated Date	May 16, 2013
Start Date ^ICMJE	April 2009
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 14, 2009)	Change in renal blood flow as assessed by 131I-Hippuran clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00881439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 14, 2009)	change in glomerular filtration rate (GFR) as assessed by 125I-Iothalamate [ Time Frame: 6 months ] [ Designated as safety issue: No ] Change in systolic and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] change in N-terminal pro brain natriuretic peptide levels (NT-proBNP) [ Time Frame: 6 months ] [ Designated as safety issue: No ] Change in left ventricular ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment
Official Title ^ICMJE	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
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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Heart Failure Kidney Failure
Intervention ^ICMJE	Drug: Aliskiren Oral, 300 mg, once daily, 6 months Other Names: Aliskiren Rasilez SPP100 Drug: Placebo Matching Placebo once daily, 6 months
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo Active Comparator: Aliskiren Intervention: Drug: Aliskiren
Publications *	McMurray JJV, Pitt B, Latini R, Maggioni AP, Solomon SD, Keefe DL, Ford J, Verma A, Lewsey J. Effects of the Oral Direct Renin Inhibitor Aliskiren in Patients With Symptomatic Heart Failure. Circulation Heart Failure 2008;1:17-24
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	41
Completion Date	December 2012
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT00881439
Other Study ID Numbers ^ICMJE	ARIANA
Has Data Monitoring Committee	Yes
Responsible Party	H.L. Hillege, University Medical Centre Groningen
Study Sponsor ^ICMJE	University Medical Centre Groningen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Medical Centre Groningen
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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