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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Heart Failure Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo once daily, 6 months

Aliskiren

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

Oral, 300 mg, once daily, 6 months

Interventions

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Aliskiren

Oral, 300 mg, once daily, 6 months

Intervention Type DRUG

Placebo

Matching Placebo once daily, 6 months

Intervention Type DRUG

Other Intervention Names

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Rasilez SPP100

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No