Heart Failure Clinical Trial
Official title:
Safety and Physiologic Effects of Implementing a High Potassium Diet in Heart Failure Patients
| NCT number | NCT03059680 |
| Other study ID # | MSH 11-0259-A |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | January 2017 |
| Verified date | February 2020 |
| Source | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | January 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum potassium concentration | 10 days and 3 weeks |
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