NEAT-HFpEF
Trial question
What is the role of isosorbide mononitrate in patients with HF and a preserved ejection fraction?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 110
110 patients (63 female, 47 male).
Inclusion criteria: patients with HF and a preserved ejection fraction.
Key exclusion criteria: SBP < 110 mmHg or > 180 mmHg or a previous adverse reaction to or current use of long-term nitrate or phosphodiesterase type 5 inhibitor therapy.
Interventions
N=51 isosorbide mononitrate (6-week dose escalation from 30 mg to 60 mg to 120 mg once daily).
N=59 placebo (matching placebo once daily for 6 weeks).
Primary outcome
Daily activity level for 120-mg dose group
8922
9303
9303.0
6977.3
4651.5
2325.8
0.0
Isosorbide
mononitrate
Placebo
No significant
difference ↔
No significant difference in daily activity level for 120-mg dose group (8922 vs. 9303).
Secondary outcomes
Significant decrease in hours of activity per day (9.01 vs. 9.31; difference -30, 95% CI -0.55 to -0.05).
Significant decrease in activity during all dose regimens (9185 vs. 9623; difference -439, 95% CI -792 to -86).
Conclusion
In patients with HF and a preserved ejection fraction, isosorbide mononitrate was not superior to placebo with respect to daily activity level for 120-mg dose group.
Reference
Redfield MM, Anstrom KJ, Levine JA et al. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24.
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