In a study of nearly 5000 patients who had heart failure with preserved ejection fraction (HFpEF), the effect size of sacubitril/valsartan vs valsartan to reduce heart failure hospitalizations or cardiovascular death did not reach statistical significance. We know better than to call a trial “negative” or “positive” based on a P value alone, but PARAGON HF confirmed the challenges of treating patients with HFpEF.
This was a global trial[1,2] of patients who had well-defined heart failure with a left ventricular ejection fraction (LVEF) greater than 45%, elevated brain natriuretic peptide, and documented structural heart disease. The investigators used equal-length run-in periods starting with valsartan, then sacubitril/valsartan, a protocol similar to that of previous HFpEF trials
Learn more about: PARAGON-HF: Heart Failure With Preserved EF Proves a Tough Foe