"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

Novartis

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Treatments

Drug: aliskiren

Study type

Interventional

Funder types

Industry

Identifiers

NCT00219011

CSPP100A2313

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.