A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
Inclusion Criteria
Patients eligible for inclusion in this study had to fulfill all of the following criteria:
Patients ≥ 18 years of age, male or female.
Patients with a diagnosis of chronic heart failure (NYHA
Class II - IV):
BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).
Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).
Written informed consent to participate in the study and ability to comply with all requirements.
Exclusion Criteria
Patients with any of the following were to be excluded from participation in the study:
Wiliamsville, New York 14221, United States
Buenos Aires, Buenos Aires C1094AAD, Argentina
Buenos Aires, Buenos Aires C1428DCO, Argentina
Caba, Buenos Aires C1180AAX, Argentina
Caba, Buenos Aires C1408INH, Argentina
Caba, Buenos Aires C1416DRJ, Argentina
Va Allende, Córdoba Province 5105, Argentina
Wooloongabba, Queensland 4102, Australia
Baranquilla, Atlántico, Colombia
Bogota, Cundinamarca 111411, Colombia
Bogotá, Cundinamarca 110111, Colombia
Pribram VIII, 261 01, Czechia
Århus N, DK-8200, Denmark
Copenhagen NV, DK-2400, Denmark
Copenhagen S, DK-2300, Denmark
Muehldorf Am Inn, 84453, Germany
Muehlheim An Der Ruhr, 45468, Germany
Hyderabad, Andhra Pradesh 500012, India
Secunderabad, Andhra Pradesh 500003, India
Co Dublin, Ireland, Ireland
Passirana Di Rho, MI 20017, Italy
Inba-gun, Chiba 270-1694, Japan
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Kita-ku, Osaka 530-0001, Japan
Adachi-ku, Tokyo 120-0006, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Bunkyo-ku, Tokyo 113-8655, Japan
Shinjuku-ku, Tokyo 162-8666, Japan
Pushkin,St-Petersburg, 196601, Russia
S.-Petersburg, 196247, Russia
Western Cape, 7130, South Africa
Niaosong Township, Taiwan 83301, Taiwan
Balcova / Izmir, 35340, Turkey (Türkiye)
Etlik / Ankara, 06018, Turkey (Türkiye)
Fatih / Istanbul, 34098, Turkey (Türkiye)
Kinikli / Denizli, 20070, Turkey (Türkiye)
East Yorkshire, HU16 5JQ, United Kingdom
Caracas, Miranda 1061, Venezuela