Heart FailureNCT03059680
Effects of Implementing a High Potassium Diet in Heart Failure Patients
A study testing High potassium diet in people with Heart Failure, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.
Trial summary
This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- High potassium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Safety and Physiologic Effects of Implementing a High Potassium Diet in Heart Failure Patients
This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.
- Conditions
- Heart Failure
- Being tested
- High potassium diet
- Keywords
- Potassium, Nutrition
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High potassium dietOther
An increase in consumption of high potassium fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: High potassium diet |
| Usual diet group | No intervention | Individuals in this group were asked to continue habitual dietary intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum potassium concentration
Measured: 10 days and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2012
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059680
- Sponsor's protocol ID
- MSH 11-0259-A
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Physiologic Effects of Implementing a High Potassium Diet in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03059680
- Acronym / sponsor ID
- MSH 11-0259-A
- Conditions
- Heart Failure
- Keywords
- Potassium, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High potassium diet group | Experimental | Other: High potassium dietIndividuals 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. |
| Usual diet group | No intervention | –Individuals in this group were asked to continue habitual dietary intake |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High potassium dietAn increase in consumption of high potassium fruits and vegetables | Other | High potassium diet group |
Primary outcome
Serum potassium concentration
Time frame: 10 days and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High potassium diet in people with Heart Failure, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum potassium concentration (time frame: 10 days and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.