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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2020
Source Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High potassium diet
An increase in consumption of high potassium fruits and vegetables

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Serum potassium concentration 10 days and 3 weeks
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