NCT03059680

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

February 16, 2017

Last Update Submit

February 18, 2020

Conditions

Heart Failure

Keywords

PotassiumNutrition

Outcome Measures

Primary Outcomes (1)

  • Serum potassium concentration

    10 days and 3 weeks

Study Arms (2)

High potassium diet group

EXPERIMENTAL

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.

Other: High potassium diet

Usual diet group

NO INTERVENTION

Individuals in this group were asked to continue habitual dietary intake

Interventions

High potassium dietOTHER

An increase in consumption of high potassium fruits and vegetables

High potassium diet group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients receiving insulin therapy
  • Glomerular filtration rate \< 40mL/min/1.73 m2
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Treating physicians and participants were not blinded to randomization. Investigators performing randomization and analysis of dietary intake were blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

January 1, 2012

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share