Dietary Sodium Intake and Outcomes in Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

Currently, the recommendations for sodium intake restriction for patients with heart failure are mostly based on expert consensus and observational evidence, whereas smaller randomized studies have actually suggested that strict dietary sodium reduction may be harmful in heart failure. In the present clinical trial pilot study, the investigators plan to collect data on enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in heart failure patients, with prepared food containing two different levels of sodium (1,500 mg and 3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The goal is to inform the design of a fullscale clinical trial that will provide more definitive evidence for dietary sodium recommendations in heart failure.

Key facts

Study ID

NCT02467296

Run by

Stony Brook University

People needed

27

Starts

2015-02-01

Expected to finish

2018-11-01

Last updated by the study team

2019-09-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥21 years at screening
• Recent (≤1 year) EF ≤40%
• Standard HF treatment, including ACEI/ARB \& beta-blockers \& aldosterone antagonists, unless contraindicated or intolerant
• Able to consume research diet (e.g. no dysphagia etc.) 6. Systolic blood pressure ≥100 mmHg 7. >3000 mg/d sodium excretion (by 24-hr urinary sodium)

You may not qualify if…

• Institutionalized patients
• Siogns or symptoms of instability in HF status
• Communication barriers, including cognitive impairment; inability to communicate and understand and cooperate with the protocol
• Severe non-cardiac illness that compromises life expectancy within the next 12 months or the ability to participate in the study (e.g. severe hepatobiliary disease, cancer underground chemo- or radiotherapy)
• Any medical or surgical procedure planned in the next 6 months
• Participants planning to move to a different state within 6 months
• Participation in any other experimental protocol
• Renal replacement therapy or Stage 4 or 5 chronic kidney disease

Where it is running

• Stony Brook University — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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