Back to results"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
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
aliskiren
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Aliskiren, heart failure,hypertension
Eligibility 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.
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00219011
Brief Title
"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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Aliskiren, heart failure,hypertension
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
280 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aliskiren
Primary Outcome Measure Information:
Title
Measurement of safety information and tolerability of drug after 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Changes in New York Heart Association heart failure stages after 12 weeks
Title
Changes from baseline in the forces of the circulation of blood as measured by echocardiography to after 12 weeks
Title
Change from baseline in mean sitting systolic and diastolic blood pressure after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
Country
United States
City
Investigative Centers
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21459891
Citation
Jackson CE, MacDonald MR, Petrie MC, Solomon SD, Pitt B, Latini R, Maggioni AP, Smith BA, Prescott MF, Lewsey J, McMurray JJ; ALiskiren Observation of heart Failure Treatment (ALOFT) investigators. Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. Eur J Heart Fail. 2011 Jul;13(7):746-54. doi: 10.1093/eurjhf/hfr031. Epub 2011 Apr 1.
Results Reference
derived
PubMed Identifier
19808266
Citation
McMurray JJ, Pitt B, Latini R, Maggioni AP, Solomon SD, Keefe DL, Ford J, Verma A, Lewsey J; Aliskiren Observation of Heart Failure Treatment (ALOFT) Investigators. Effects of the oral direct renin inhibitor aliskiren in patients with symptomatic heart failure. Circ Heart Fail. 2008 May;1(1):17-24. doi: 10.1161/CIRCHEARTFAILURE.107.740704.
Results Reference
derived
Learn more about this trial
"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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