Effects of Implementing a High Potassium Diet in Heart Failure Patients

NCT ID: NCT03059680

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-01-31

Brief Summary

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High potassium diet group

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.

Group Type: EXPERIMENTAL

High potassium diet

Intervention Type: OTHER

An increase in consumption of high potassium fruits and vegetables

Usual diet group

Individuals in this group were asked to continue habitual dietary intake

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High potassium diet

An increase in consumption of high potassium fruits and vegetables

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MSH 11-0259-A

Identifier Type: -

Identifier Source: org_study_id