Status:
COMPLETED
Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Decompensated systolic heart failure, left ventricular ejection fraction ≤40%
- Brain natriuretic peptide (BNP) level ≥ 100 pg/mL
- Exclusion criteria:
- Use of Angiotensin Converting Enzyme(ACE) or Angiotensin Receptor Blocker (ARB) inhibitor treatment following the run-in period or requirement of both treatments
- Acute heart failure secondary to acute myocardial infarction, acute coronary syndrome or new tachyarrhythmia
- Occurrence of unstable angina or myocardial infarction within 12 weeks prior to screening
- History of cardiomyopathy such as postpartum, restrictive, infective, hypertrophic obstructive
- History of right heart failure due to pulmonary disease
- History of untreated second or third degree atrioventricular heart block
- Other protocol-defined inclusion/exclusion criteria applied
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00923156
Start Date
May 1 2009
End Date
February 1 2011
Last Update
July 26 2012
Active Locations (16)
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1
Novartis Investigator Site
Bad Krozingen, Germany, 79189
2
Novartis Investigator Site
Berlin, Germany, 12207
3
Novartis Investigator Site
Berlin, Germany, 13353
4
Novartis Investigator Site
Göttingen, Germany, 37057