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

Condition(s) targeted: Heart Failure

Intervention: aliskiren (Drug); ramipril (Drug); aliskiren plus ramipril (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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 worsening of heart failure. Therefore the study will test the effects of ramipril, aliskiren and the combination of both on levels on angiotensin II in the blood in patients with systolic heart failure.

Official title: A Double-Blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Effects of Aliskiren, Ramipril and Combination Treatment on Plasma Concentration of Angiotensin II in Patients With Decompensated Chronic Systolic Heart Failure

Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome: Angiotensin II

Secondary outcome:

Other biomarkers

Aliskiren Plasma Concentration (PK)

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Decompensated chronic systolic heart failure

- Brain natriuretic peptide (BNP) level ≥ 100 pg/mL

Exclusion criteria:

- History of requirement of both ACE and ARB inhibitor treatment

- 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 may apply

Novartis Investigator Site, Berlin 12207, Germany; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Göttingen 37057, Germany; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Berlin 13353, Germany; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Bad Krozingen 79189, Germany; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Jena 07747, Germany; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, München 80336, Germany; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Wroclaw 50-981, Poland; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Poznan 61-848, Poland; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Warszawa 02-507, Poland; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Lublin 20-090, Poland; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Krakow 31-501, Poland; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Moscow 117292, Russian Federation; Not yet recruiting
Nov, Phone: +41 61 324 1111

Novartis Investigator Site, Moscow 119620, Russian Federation; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Moscow 121309, Russian Federation; Recruiting
Novartis Germany, Phone: +41 61 324 1111

Novartis Investigator Site, Moscow 121552, Russian Federation; Not yet recruiting
Novartis Germany, Phone: +41 61 324 1111

Starting date: May 2009
Last updated: June 17, 2009