“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 - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219011

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: aliskiren	Phase III

MedlinePlus related topics: Heart Failure High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Measurement of safety information and tolerability of drug after 12 weeks

Secondary Outcome Measures:

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

Estimated Enrollment:	280
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219011

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CSPP100A2313
Study First Received:	September 12, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00219011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Aliskiren, heart failure,hypertension

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009