ALOFT - Aliskiren Observation of Heart Failure Treatment: Efficacy and Safety of Aliskiren Added on Top of Standard Therapy in Adults (≥ 18 Years) With Stable Heart Failure

Study Overview
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Brief Summary
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This study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in their heart failure signs and symptoms and other indicators of heart failure after being treated with aliskiren on top of their current heart failure treatment. Aliskiren is an investigational drug; its safety will also be evaluated in this trial.

Official Title
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A Twelve-week, Randomized, Double-blind, Multi-center, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Aliskiren 150 mg When Added to Standard Therapy in Hypertensive Patients With Stable Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: aliskiren


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of diagnosis or currently have high blood pressure Stable heart failure (NYHA Class 2-4) for at least 1 month before study entry. Subject should be on a stable dose regimen of heart failure medication. Brain natriuretic peptide (BNP) > 150 pg/ml at baseline (to be evaluated by physician at first visit) Exclusion Criteria: Previous treatment with aliskiren High blood pressure due to secondary reasons or constant low blood pressure (systolic < 90 mmHg) History of heart attack or coronary bypass surgery in the past 6 months Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aliskiren|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of safety information and tolerability of drug after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the heart failure biochemical markers of N-terminal pro-brain natriuretic peptide (NT-proBNP) and brain natriuretic (BNP) after 12 weeks |  |  | 
| Change from baseline in aldosterone (a steroid hormone secreted by the adrenal cortex that regulates salt and water balance in the body) after 12 weeks |  |  | 
| Changes in New York Heart Association heart failure stages after 12 weeks |  |  | 
| Changes from baseline in the forces of the circulation of blood as measured by echocardiography to after 12 weeks |  |  | 
| Change from baseline in mean sitting systolic and diastolic blood pressure after 12 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aliskiren, heart failure,hypertension