Back to resultsEffects of Implementing a High Potassium Diet in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High potassium diet
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Potassium, Nutrition
Eligibility Criteria
Inclusion Criteria:
- All patients classified as having HF, both systolic and diastolic.
- New York Heart Association class II-III symptoms.
- Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous month
- Intake at baseline of ≤ 3 servings of fruits and vegetables per day. Servings defined by Health Canada's food guide.
Exclusion Criteria:
- Patients with an episode of decompensated heart failure, acute coronary syndrome, or revascularization within the previous 3 months of study inclusion.
- Patients receiving insulin therapy
- Glomerular filtration rate < 40mL/min/1.73 m2
- Pregnancy and lactation (women of childbearing potential will be included but will have to have a negative pregnancy test prior to inclusion).
- Inability to provide informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High potassium diet group
Usual diet group
Arm Description
Individuals in this arm were asked to increase dietary potassium intake over a 4 week period. This was achieved through an increase in consumption of fruits and vegetables.
Individuals in this group were asked to continue habitual dietary intake
Outcomes
Primary Outcome Measures
Serum potassium concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT03059680
First Posted
February 16, 2017
Last Updated
February 18, 2020
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03059680
Brief Title
Effects of Implementing a High Potassium Diet in Heart Failure Patients
Official Title
Safety and Physiologic Effects of Implementing a High Potassium Diet in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Potassium, Nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Treating physicians and participants were not blinded to randomization. Investigators performing randomization and analysis of dietary intake were blinded.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High potassium diet group
Arm Type
Experimental
Arm Description
Individuals in this arm were asked to increase dietary potassium intake over a 4 week period. This was achieved through an increase in consumption of fruits and vegetables.
Arm Title
Usual diet group
Arm Type
No Intervention
Arm Description
Individuals in this group were asked to continue habitual dietary intake
Intervention Type
Other
Intervention Name(s)
High potassium diet
Intervention Description
An increase in consumption of high potassium fruits and vegetables
Primary Outcome Measure Information:
Title
Serum potassium concentration
Time Frame
10 days and 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients classified as having HF, both systolic and diastolic.
New York Heart Association class II-III symptoms.
Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous month
Intake at baseline of ≤ 3 servings of fruits and vegetables per day. Servings defined by Health Canada's food guide.
Exclusion Criteria:
Patients with an episode of decompensated heart failure, acute coronary syndrome, or revascularization within the previous 3 months of study inclusion.
Patients receiving insulin therapy
Glomerular filtration rate < 40mL/min/1.73 m2
Pregnancy and lactation (women of childbearing potential will be included but will have to have a negative pregnancy test prior to inclusion).
Inability to provide informed consent.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Implementing a High Potassium Diet in Heart Failure Patients
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