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

May 16, 2013 updated by: H.L. Hillege, University Medical Center Groningen

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARIANA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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