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Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction
Open accessAbstract
BACKGROUND: Nitrates are commonly prescribed to enhance activity tolerance in patients with heart failure and a preserved ejection fraction. We compared the effect of isosorbide mononitrate or placebo on daily activity in such patients. METHODS: In this multicenter, double-blind, crossover study, 110 patients with heart failure and a preserved ejection fraction were randomly assigned to a 6-week dose-escalation regimen of isosorbide mononitrate (from 30 mg to 60 mg to 120 mg once daily) or placebo, with subsequent crossover to the other group for 6 weeks. The primary end point was the daily activity level, quantified as the average daily accelerometer units during the 120-mg phase, as assessed by patient-worn accelerometers. Secondary end points included hours of activity per day during the 120-mg phase, daily accelerometer units during all three dose regimens, quality-of-life scores, 6-minute walk distance, and levels of N-terminal pro-brain natriuretic peptide (NT-proBNP). RESULTS: In the group receiving the 120-mg dose of isosorbide mononitrate, as compared with the placebo group, there was a nonsignificant trend toward lower daily activity (-381 accelerometer units; 95% confidence interval [CI], -780 to 17; P=0.06) and a significant decrease in hours of activity per day (-0.30 hours; 95% CI, -0.55 to -0.05; P=0.02). During all dose regimens, activity in the isosorbide mononitrate group was lower than that in the placebo group (-439 accelerometer units; 95% CI, -792 to -86; P=0.02). Activity levels decreased progressively and significantly with increased doses of isosorbide mononitrate (but not placebo). There were no significant between-group differences in the 6-minute walk distance, quality-of-life scores, or NT-proBNP levels. CONCLUSIONS: Patients with heart failure and a preserved ejection fraction who received isosorbide mononitrate were less active and did not have better quality of life or submaximal exercise capacity than did patients who received placebo. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT02053493.).
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The nitrate-nitrite-nitric oxide pathway in physiology and therapeutics
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Irbesartan in patients with heart failure and preserved ejection fraction
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Self-citationCross‐over Trials In Clinical Research
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Levine, J. A. (2005) · Public Health Nutrition · doi:10.1079/phn2005800 · Cited by 401
Self-citationLeier, C. V., Huss, P., Magorien, R. D., & Unverferth, D. V. (1983) · Circulation · doi:10.1161/01.cir.67.4.817 · Cited by 289
Cardiovascular drug therapy in the elderly: benefits and challenges
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Patient selection in heart failure with preserved ejection fraction clinical trials
Kelly, J. P., Mentz, R. J., Mebazaa, A., Voors, A. A., Butler, J., Roessig, L., Fiuzat, M., Zannad, F., Pitt, B., O’Connor, C. M., et al. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.03.043 · Cited by 139
Effects of physical activity and sedentary time on the risk of heart failure
Young, D. R., Reynolds, K., Sidell, M., Brar, S., Ghai, N. R., Sternfeld, B., Jacobsen, S. J., Slezak, J. M., Caan, B., & Quinn, V. P. (2014) · Circulation: Heart Failure · doi:10.1161/circheartfailure.113.000529 · Cited by 125
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2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure
McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab368 · Cited by 13,344
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Circulation · doi:10.1161/cir.0000000000001063 · Cited by 4,922
2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure
Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Colvin, M. M., Drazner, M. H., Filippatos, G. S., Fonarow, G. C., Givertz, M. M., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.04.025 · Cited by 3,418
Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Colvin, M. M., Drazner, M. H., Filippatos, G. S., Fonarow, G. C., Givertz, M. M., et al. (2017) · Circulation · doi:10.1161/cir.0000000000000509 · Cited by 3,109
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.12.012 · Cited by 2,862
Metadata
- Authors
- Redfield, M. M., Anstrom, K. J., Levine, J. A., Koepp, G. A., Borlaug, B. A., Chen, H. H., LeWinter, M. M., Joseph, S. M., Shah, S. J., Semigran, M. J., Felker, G. M., Cole, R. T., Reeves, G. R., Tedford, R. J., Tang, W. H. W., McNulty, S. E., Velazquez, E. J., Shah, M. R., & Braunwald, E.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-12-10
- Volume
- 373
- Issue
- 24
- Pages
- 2314-2324
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2213926659
- Cited by
- 549
- References
- 10
- FWCI
- 34.80
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Redfield, M. M., Anstrom, K. J., Levine, J. A., Koepp, G. A., Borlaug, B. A., Chen, H. H., LeWinter, M. M., Joseph, S. M., Shah, S. J., Semigran, M. J., Felker, G. M., Cole, R. T., Reeves, G. R., Tedford, R. J., Tang, W. H. W., McNulty, S. E., Velazquez, E. J., Shah, M. R., & Braunwald, E. (2015). Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1510774
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.