Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF) - 17/12/18
on behalf of the SODIUM-HF investigators
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.
Il testo completo di questo articolo è disponibile in PDF.Mappa
| Philip F. Binkley, MD, MPH, served as guest editor for this article. |
|
| RCT# NCT02012179 |
|
| Funding: SODIUM-HF (www.sodiumhftrial.com) is funded by the Canadian Institutes of Health Research (CIHR MOP 130275) and the University Hospital Foundation (Edmonton, Alberta, Canada). |
|
| Disclosures: none. |
Vol 205
P. 87-96 - Novembre 2018 Ritorno al numero
Articolo precedente
- Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial
- Nicolas M. Van Mieghem, Martin Unverdorben, Marco Valgimigli, Roxana Mehran, Eric Boersma, Usman Baber, Christian Hengstenberg, Minggao Shi, Cathy Chen, Shigeru Saito, Roland Veltkamp, Pascal Vranckx, George D. Dangas
- Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER)
- Niels Ramsing Holm, Lene Nyhus Andreasen, Simon Walsh, Olli A. Kajander, Nils Witt, Christian Eek, Paul Knaapen, Lukasz Koltowski, Juan Luis Gutiérrez-Chico, Francesco Burzotta, Janusz Kockman, John Ormiston, Irene Santos-Pardo, Peep Laanmets, Darren Mylotte, Morten Madsen, Jakob Hjort, Indulis Kumsars, Truls Råmunddal, Evald Høj Christiansen
Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.
Già abbonato a @@106933@@ rivista ?