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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219011

Enrollment

280

Registered

2005-09-22

Start date

2005-05-31

Completion date

2007-02-28

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Aliskiren, heart failure,hypertension

Brief 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.

Interventions

DRUGaliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Measurement of safety information and tolerability of drug after 12 weeks	—

Secondary

Measure	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	—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026