Eloisa Colin-Ramirez1, Justin A Ezekowitz2. 1. National Council of Science and Technology (CONACYT), and National Institute of Cardiology 'Ignacio Chavez', Mexico City, Mexico; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada. 2. Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. Electronic address: jae2@ualberta.ca.
Abstract
BACKGROUND:Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF. METHODS: The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients. CONCLUSIONS: The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
RCT Entities:
BACKGROUND:Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF. METHODS: The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients. CONCLUSIONS: The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.
Authors: Alan S Go; Thida C Tan; Kate M Horiuchi; Denise Laws; Andrew P Ambrosy; Keane K Lee; Benjamin L Maring; Jena Joy; Cathryn Couch; Paul Hepfer; Joan C Lo; Rishi V Parikh Journal: Med Care Date: 2022-08-15 Impact factor: 3.178
Authors: Anand Ganes; Jessica A Davis; Jyrki K Virtanen; Ari Voutilainen; Tomi-Pekka Tuomainen; John J Atherton; John Amerena; Andrea Driscoll; Dave L Hare; Gary Wittert; Anu Ruusunen; Wolfgang Marx; Mohammadreza Mohebbi; Adrienne O'Neil Journal: BMC Cardiovasc Disord Date: 2022-09-02 Impact factor: 2.174