"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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

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.