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

June 7, 2022 updated by: University of Alberta

The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure

This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.

Exclusion Criteria:

  • Subjects will be excluded if they have severe hyponatremia (serum sodium <130 mmol/L)
  • Renal failure (a glomerular filtration rate < 30 mL/min)
  • Uncontrolled thyroid disorders
  • Hepatic failure
  • Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
  • Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
  • Malignancy, or with moderate-severe dementia.
  • Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: low-sodium diet
(1500 mg daily)
Other: low-sodium diet (1500 mg daily)
NO_INTERVENTION: moderate-sodium diet
sodium (100 mmol or 2300 mg daily; Usual Care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite clinical outcomes
Time Frame: 12 months
(cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms and quality of life
Time Frame: 12 months
improves symptoms and quality of life for patients with stable HF
12 months
reduces natriuretic peptide levels
Time Frame: 12 months
reduces natriuretic peptide levels
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (ESTIMATE)

November 28, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82-SH-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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