Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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 of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the blood in patients with systolic heart failure

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Angiotensin II; Angiotensinogen; Ramipril

Criteria

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