PARALLAX meets one primary endpoint in heart failure with preserved ejection fraction

The trial met the first primary endpoint: after 12 weeks, patients treated with sacubitril/valsartan showed a highly significant 16.4% greater reduction in NT-proBNP than patients treated with optimal individualised medical therapy (p<0.0001).

The trial did not meet the second primary endpoint: at week 24, six-minute walk distance had improved in both groups compared to baseline (mean change was 9.7 m in the sacubitril/valsartan group and 12.2 m in the individualised medical therapy group), with no significant difference between groups (mean difference -2.5 m; 95% confidence interval -8.5 to 3.5 m; p=0.79).

Secondary endpoints included change from baseline to 24 weeks in quality of life (measured by the Kansas City Cardiomyopathy Questionnaire; KCCQ) and New York Heart Association (NYHA) functional class. Quality of life improved in both groups and was better with sacubitril/valsartan than the comparator at week 4 but there was no difference between groups at week 24. Changes in NYHA class were similar in both groups at week 24.

Overall, except for heart failure events, serious adverse events were reported in similar proportions of patients in both groups. Heart failure events (such as worsening heart failure requiring hospitalisation or not necessitating hospital admission) were the most common serious adverse events and occurred in more patients in the individualised medical therapy group than in the sacubitril/valsartan group. Based on this, a post hoc analysis showed that sacubitril/valsartan reduced the risk for heart failure hospitalisation by 50% (p=0.005). Patients in the sacubitril/valsartan group also had a significantly lower decline in renal function (estimated glomerular filtration rate; eGFR) at 24 weeks.

Principal investigator Professor Burkert Pieske from Charité University Medicine Berlin and the German Heart Centre, Berlin said: “The trial showed a consistent decline of the surrogate outcome marker NT-proBNP with sacubitril/valsartan, as compared to individual medical therapy.”

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