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Dietary Sodium Intake and Outcomes in Heart Failure

NCT02467296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-09-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Dietary plan with controlled amount of Sodium

Dietary plan with 1.5 gr vs 3 gr of Sodium

Sponsors & Collaborators

Principal Investigators

  • Javed Butler, MD, MPH, MBA · Stony Brook University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-07-31
Completion
2018-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467296 on ClinicalTrials.gov