Heart Failure
Conditions
Keywords
Patients with stable heart failure
Brief summary
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
Interventions
OTHERlow-sodium diet (1500 mg daily)
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite clinical outcomes | 12 months | (cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptoms and quality of life | 12 months | improves symptoms and quality of life for patients with stable HF |
| reduces natriuretic peptide levels | 12 months | reduces natriuretic peptide levels |
Countries
Canada
Outcome results
None listed