"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

Completed · Phase 3

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00219011

Run by

Novartis

People needed

280

Starts

2005-05-01

Expected to finish

2007-02-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States
• Study site — Investigative Centers, Germany

Full record on ClinicalTrials.gov

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