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Clinical Trials/NCT01480401
NCT01480401
Completed
Not Applicable

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

University of Alberta1 site in 1 country38 target enrollmentMarch 2012
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ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Alberta
Enrollment
38
Locations
1
Primary Endpoint
composite clinical outcomes
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
November 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • reduces natriuretic peptide levels(12 months)
  • symptoms and quality of life(12 months)

Study Sites (1)

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