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"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

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ClinicalTrials.gov Identifier: NCT00219011
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: aliskiren Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Other
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
Study Start Date : May 2005
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Aliskiren
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Measurement of safety information and tolerability of drug after 12 weeks

Secondary Outcome Measures :
  1. 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
  2. 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
  3. Changes in New York Heart Association heart failure stages after 12 weeks
  4. Changes from baseline in the forces of the circulation of blood as measured by echocardiography to after 12 weeks
  5. Change from baseline in mean sitting systolic and diastolic blood pressure after 12 weeks

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Novartis Pharmaceuticals
More Information