ATMOSPHERE, trial summary

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A randomised clinical trial investigating the effect of aliskiren versus Enalapril in patients with chronic heart failure NYHA Class II - IV.

        Z

NCT00853658    N Engl J Med 2016;374:1521-32  



Studied treatment Aliskiren 150 mg titrated to 300 mg
Control treatment enalapril 10 mg

3rd arm with Aliskiren / Enalapril combination therapy



Patients patients with chronic heart failure NYHA Class II - IV.
Group sizes-9 / -9
Inclusion criteriachronic heart failure (NYHA Class II - IV): LVEF <= 35% (local measurement, measured within the past 6 months assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography), or Elevated BNP >= 150 pg/ml (according to local measurement), or BNP >= 100 pg/ml (according to local measurement) and unplanned hospitalization with HF within the last 12 months; Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg daily at least or any other ACE inhibitor, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses as described in the dose equivalence guidance table of ACEi's) for at least 4 weeks



Blindness double blind Inclusion period
Follow-up duration Centers
Lost to FU planned for 4 y geographical localisation
Primary endpoint cardiovascular death or heart failure hospitalization Design Parallel groups



EndpointX1N1X0N0TE95% CI CVdeath or heart failure rehospitalization - -9 - -9 no data CV death - -9 - -9 no data Heart-failure rehospitalization - -9 - -9 no data Hypotension - -9 - -9 no data Hyperkalemia - -9 - -9 no data Renal impairment/failure - -9 - -9 no data0,22,01,0

McMurray JJ, Krum H, Abraham WT, Dickstein K, Køber LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med 2016;374:1521-32     [PMID: 27043774]   link to pdf   add to Mendeley  

McMurray JJ, Krum H, Abraham WT, Dickstein K, Køber LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med 2016;374:1521-32     [PMID: 27043774]   link to pdf   add to Mendeley  

Links

http://www.medscape.com/viewarticle/862249

ClinicalTrial.gov record NCT00853658



Registering number NCT00853658 (see trial on clinicaltrials.gov)
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All trials of aliskiren

Appears in following systematic reviews: