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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of safety information and tolerability of drug after 12 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21459891 | Derived | 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. | |
| 19808266 |
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| 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 |
| Investigative Centers |
| Germany |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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