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Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure

NCT03351283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-09-09

No results posted yet for this study

Summary

The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of moderate to severe sodium restriction on brain natriuretic peptide in patients with heart failure and reduced ejection fraction (less than 40%).

Secondary outcomes are quality of life, NYHA functional class, glomerular filtration rate, renin plasmatic activity, aldosterone and composite clinical outcome (all-cause mortality and cardiovascular hospitalization)

Conditions

  • Diet, Sodium-Restricted
  • Heart Failure, Systolic
  • Natriuretic Peptide, Brain
  • Clinical Trial

Interventions

OTHER

Severe sodium restriction

Patients will be assigned to a diet with sodium restriction of two grams.

OTHER

Moderate sodium restriction

Patients will be assigned to a diet with sodium restriction of three grams.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Juan B Ivey-Miranda, MD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2019-11-01
Completion
2020-08-01

Countries

  • Mexico

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 NCT03351283 on ClinicalTrials.gov