At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7,064 enrolled
Drug / intervention
Enalapril +1 moredrug
Likely dose
Aliskiren 150 mg titrated to 300 mg once daily; Enalapril 10 mg once dailyAI-extracted
Key inclusion· 5
- ✓Age ≥18 years
- ✓Chronic heart failure NYHA Class II-IV with LVEF ≤35% (within past 6 months)
- ✓Elevated BNP (≥150 pg/mL or ≥100 pg/mL with prior HF hospitalization) or NT-proBNP (≥600 pg/mL or ≥400 pg/mL with prior HF hospitalization)
- ✓Stable ACEI therapy (enalapril ≥10 mg daily or equivalent) for ≥4 weeks prior to Visit 1
Key exclusion· 8
- ✕Hypersensitivity or allergy to study drugs (including ACEIs) or known/suspected contraindications
- ✕Concomitant ARB and aldosterone antagonist therapy in addition to study drug at Visit 1
- ✕Current acute decompensated heart failure
- ✕Symptomatic hypotension or SBP <95 mmHg at Visit 1 or <90 mmHg at Visit 4
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 3 clinical trial evaluating Enalapril and Aliskiren for Chronic Heart Failure. Completed, enrolled 7,064 participants across 806 sites in 44 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czechia, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionOct 2015
TodayJul 2026
First PostedMar 2, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 17.3 years ago
Interventions
Enalaprildrug
Enalapril 10 mg film-coated tablet and administered orally.
Aliskirendrug
Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.