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Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure

NCT04334668 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-02-20

Study results available
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Summary

The investigators are proposing a prospective, randomized, double blinded, placebo-controlled single center study evaluating the role of co-administration of oral sodium chloride (NaCl) with intravenous diuretics in patients hospitalized with acute decompensated heart failure. The investigators are approaching this study with the hypothesis that the use of oral sodium chloride leads to improved effective diuresis (as measured by weight loss) and renal function as compared to placebo in patients hospitalized with acute decompensated heart failure undergoing aggressive intravenous diuretic therapy.

Conditions

  • Volume Overload

Interventions

DIETARY_SUPPLEMENT

Oral Sodium Chloride

Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days

OTHER

Placebo

Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • W. H. Wilson Tang, MD · The Cleveland Clinic

  • Robert A Montgomery, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2022-06-01
Completion
2026-12-31

Countries

  • United States

Study Locations

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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 NCT04334668 on ClinicalTrials.gov