Heart failure & cardiomyopathies
Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial
Primary result · NT-proBNP change from baseline at week 12Result — go to the resultAdjusted geometric mean ratio 0.84 95% CI 0.80–0.88Authors' conclusion
Among patients with heart failure and left ventricular ejection factor of higher than 40%, sacubitril/valsartan treatment compared with standard renin angiotensin system inhibitor treatment or placebo resulted in a significantly greater decrease in plasma N-terminal pro-brain natriuretic peptide levels at 12 weeks but did not significantly improve 6-minute walk distance at 24 weeks.
Study context
- Population
- Patients with chronic HF, LVEF >40%, elevated NT-proBNP, structural heart disease and reduced quality of life2,240 (87.1%) completed
- Participants
- 2,572 patients
- Comparison
- Sacubitril/valsartan vs background medication-based individualized comparator
- Sacubitril/valsartann = 1,286
- Comparatorn = 1,286reference
- Primary endpoint
- Change from baseline in plasma NT-proBNP (week 12) and in 6-minute walk distance (week 24)
- Follow-up
- 12 and 24 weeks
Methodological detailsdouble-blind, parallel group, multicentre (396 centres, 32 countries)
- Double-blind
- Parallel group
- Multicentre (396 centres, 32 countries)
Primary result
NT-proBNP change from baseline at week 12
Adjusted geometric mean ratio
0.84
95% CI 0.80–0.88
P < 0.001
By group
As reported in the abstract
Secondary outcomes
- KCCQ clinical summary score, mean change from baseline · 24 weeks — Sacubitril/valsartan
- mean change 12.3
Safety
Most frequent adverse events: hypotension, albuminuria, hyperkalemia
Hypotension
Albuminuria
Hyperkalemia
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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