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Dietary Intervention

Low sodium diet for Heart Failure (SODIUM-HF Trial)

Phase 3

Waitlist Available

Led By Justin Ezekowitz, MBBCh

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SODIUM-HF Trial Summary

This trial is testing whether a low sodium diet can help people with chronic heart failure by reducing the number of hospitalizations and emergency department visits, and increasing survival.

SODIUM-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SODIUM-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Clinical Outcomes

Secondary outcome measures

Exercise capacity

NYHA functional class

Quality of life (KCCQ)

SODIUM-HF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low sodium dietExperimental Treatment1 Intervention

Low sodium diet (65 mmol or 1500 mg/day)

Group II: Usual CareActive Control1 Intervention

General advice to limit dietary sodium as it is provided during routine clinic practice

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

383,972 Total Patients Enrolled

25 Trials studying Heart Failure

4,827 Patients Enrolled for Heart Failure

Justin Ezekowitz, MBBChPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

51 Total Patients Enrolled

1 Trials studying Heart Failure

51 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide the total number of research facilities where this trial is being conducted?

"Right now, there are 17 different locations where this clinical trial is recruiting patients from. The sites are situated in Toronto, Hamilton, Red Deer, and 14 other places. If you want to limit your travel, you should select the location that is closest to you."

Answered by AI

What are the risks associated with a Low sodium diet?

"Low sodium diet received a score of 3 because there is prior clinical data supporting its safety, as well as efficacy."

Answered by AI

Are people who are sick able to participate in this research project at this time?

"No, this particular trial is not looking for more patients at the moment. It was initially posted on March 24th, 2014, and was last updated on July 7th, 2022. That being said, there are 735 other trials that are actively recruiting."

Answered by AI

Recent research and studies

American Heart JournalJournal

Rationale and Design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)

Colin-Ramirez, Eloisa, and Justin A. Ezekowitz. 2018. “Rationale and Design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2018.08.005.

The LancetJournal

Reduction of Dietary Sodium to Less Than 100 Mmol in Heart Failure (SODIUM-HF): An International, Open-label, Randomised, Controlled Trial

Ezekowitz, Justin A, Eloisa Colin-Ramirez, Heather Ross, Jorge Escobedo, Peter Macdonald, Richard Troughton, Clara Saldarriaga, et al.. 2022. “Reduction of Dietary Sodium to Less Than 100 Mmol in Heart Failure (SODIUM-HF): An International, Open-label, Randomised, Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(22)00369-5.

The LancetJournal

Reduction of Dietary Sodium to Less Than 100 Mmol in Heart Failure (SODIUM-HF): An International, Open-label, Randomised, Controlled Trial

clinicaltrials.govStudy

SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure