• Barry A Borlaug, Katlyn E Koepp, ReddyYogesh N VYNVDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN., Masaru Obokata, Hidemi Sorimachi, Monique Freund, Doug Haberman, Kara Sweere, Kari L Weber, Elysha A Overholt, Bethany A Safe, Kazunori Omote, Massar Omar, Dejana Popovic, Nancy G Acker, Mark T Gladwin, Thomas P Olson, and Rickey E Carter.
• Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN. Electronic address: borlaug.barry@mayo.edu.
• Mayo Clin. Proc. 2024 Feb 1; 99 (2): 206217206-217.

ObjectiveTo determine whether nitrite can enhance exercise training (ET) effects in heart failure with preserved ejection fraction (HFpEF).MethodsIn this multicenter, double-blind, placebo-controlled, randomized trial conducted at 1 urban and 9 rural outreach centers between November 22, 2016, and December 9, 2021, patients with HFpEF underwent ET along with inorganic nitrite 40 mg or placebo 3 times daily. The primary end point was peak oxygen consumption (VO2). Secondary end points included Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS, range 0 to 100; higher scores reflect better health status), 6-minute walk distance, and actigraphy.ResultsOf 92 patients randomized, 73 completed the trial because of protocol modifications necessitated by loss of drug availability. Most patients were older than 65 years (80%), were obese (75%), and lived in rural settings (63%). At baseline, median peak VO2 (14.1 mL·kg-1·min-1) and KCCQ-OSS (63.7) were severely reduced. Exercise training improved peak VO2 (+0.8 mL·kg-1·min-1; 95% CI, 0.3 to 1.2; P<.001) and KCCQ-OSS (+5.5; 95% CI, 2.5 to 8.6; P<.001). Nitrite was well tolerated, but treatment with nitrite did not affect the change in peak VO2 with ET (nitrite effect, -0.13; 95% CI, -1.03 to 0.76; P=.77) or KCCQ-OSS (-1.2; 95% CI, -7.2 to 4.9; P=.71). This pattern was consistent across other secondary outcomes.ConclusionFor patients with HFpEF, ET administered for 12 weeks in a predominantly rural setting improved exercise capacity and health status, but compared with placebo, treatment with inorganic nitrite did not enhance the benefit from ET.Trial RegistrationClinicalTrials.gov identifier: NCT02713126.Copyright © 2023 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

18 keywords...

hide…