Study of Dietary Intervention Under 100 MMOL in Heart Failure
Not Applicable
Completed
- Conditions
- Heart Failure
- Interventions
- Other: low-sodium diet (1500 mg daily)
- Registration Number
- NCT01480401
- Lead Sponsor
- University of Alberta
- Brief Summary
This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low-sodium diet low-sodium diet (1500 mg daily) (1500 mg daily)
- Primary Outcome Measures
Name Time Method composite clinical outcomes 12 months (cardiovascular hospitalizations, emergency department visits due acute decompensated HF, and all-cause mortality) in patients with stable HF
- Secondary Outcome Measures
Name Time Method reduces natriuretic peptide levels 12 months reduces natriuretic peptide levels
symptoms and quality of life 12 months improves symptoms and quality of life for patients with stable HF
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada