Heart Failure With Preserved Ejection FractionNCT04235699
Ketogenic Diet in Patients With Heart Failure
A study testing Nutritional and Dietary Manipulation in people with Heart Failure With Preserved Ejection Fraction, run by Ohio State University at 1 site in United States.
Trial summary
This study is being done to evaluate the effects of a low carbohydrate ketogenic diet on exercise tolerance in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), also known as Diastolic Heart Failure (DHF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Nutritional and Dietary Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2019to 31 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and ≤ 75 years old \& willingness to be randomized to either diet
- Confirmed diagnosis of heart failure with ejection fraction ≥50% (NYHA Class II-IV)
- On optimal medical therapy for at least 3 months as determined by the treating physician
- Body Mass Index (BMI) ≥ 25
- Ability to participate in exercise treadmill testing
Who cannot join
- Contraindications to MRI including pregnancy
- Diagnosis of diabetes mellitus treated with insulin or SGLT2 inhibitors.
- History of diabetic ketoacidosis
- Recent (within 30 days) or planned (within 30 days) cardiac revascularization
- Recent acute myocardial infarction or acute coronary syndrome (30 days)
- Body Mass Index (BMI) < 25, or BMI > 40
Show all 14Show fewer
- Hepatic cirrhosis
- Use of metformin > 1700 mg daily
- Left ventricular ejection fractions < 50%
- Prior diagnosis of moderate to severe COPD
- Uncontrolled systemic systolic/diastolic hypertension (SBP > 150 mmHg or DBP > 90 mmHg)
- Echocardiographic evidence of significant valvular disease
- History of ventricular tachycardia or SCD
- Untreated moderate or severe sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Ketogenic Diet in Patients With Heart Failure With Preserved Ejection Fraction: A Pilot Study
This study is being done to evaluate the effects of a low carbohydrate ketogenic diet on exercise tolerance in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), also known as Diastolic Heart Failure (DHF).
Read the detailed description
Patients will be randomized to either a ketogenic diet, or a low-fat diet higher in carbohydrate and based on current dietary guidelines. Regardless of what group you are randomized to, you will consume the diet for a period of 4 weeks. All foods will be prepared by our research group and provided to you. Both diets will be based on an approximately 25% reduction in your dietary caloric requirements, so some weight loss may occur over the 4-week intervention.
Primary data collection will occur at baseline and at four weeks, with more frequent monitoring of blood markers, blood pressure, heart rate, and overall health. Throughout the duration of the study, you will be continued on standard heart failure therapies as guided by your treating physician. The duration of the study is expected to last for approximately 6 weeks. This includes all before and after testing, as well as the 4 weeks on diet.
All patients will undergo a resting MRI scan of the heart at enrollment (baseline), and again at the end of the 4-week diet. You will not receive any injections.
All participants will also undergo a cardiopulmonary stress test (CPET, also known as VO2 testing) at enrollment (baseline) and again at the end of the 4-week dietary intervention. During the Cardiopulmonary stress testing you will be asked to exercise on a treadmill while breathing into a mask.
All participants will also undergo body fat and body fluid composition by dual-energy X-ray absorptiometry (DXA) at enrollment (baseline) and again at the end of the 4 week dietary intervention. You will be exposed to a very small amount of radiation by the DXA scanner used to measure your body composition. However, amount of radiation used in DXA is extremely low (by comparison, a standard chest x-ray is 125 times more radiation than a DXA scan).
Blood tests will be performed at enrollment (baseline) and again at the end of the 4 week dietary intervention. Blood draws may cause discomfort at the skin puncture site and a small bruise may develop that may persist for several weeks. There is also a small possibility of an infection. These risks are identical to standard clinical blood draws.
After 2-weeks, and again after 4 weeks on diet, all participants will undergo a clinical examination by a cardiologist.
All participants will be provided with a handheld glucometer and test strips to check ketone levels daily in the morning after an overnight fast. This requires a finger prick to obtain the drop of blood required for the test. The finger stick may cause a slight immediate discomfort at the specific stick site. Subjects will also be required to check and record ketones 4x/day on one day per week to capture a more accurate record of ketone levels during waking hours. You will bring the glucometer readings with you when you pick up food so that the results can be downloaded and recorded by a member of the research team.
Patients on either diet will personally pick up food 3X per week. Patients will weigh-in and have their heart rate and blood pressure checked at the time of each food pick up. The MRI, the cardiopulmonary stress test and all blood testing will be done at the Ross Heart Hospital or the Davis Heart and Lung Research Institute. The DXA testing, as well as the food pickup will be done at the Physical Activity and Educational Services (PAES) building on The Ohio State University campus.
- Being tested
- Nutritional and Dietary Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and Dietary ManipulationOther
Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | This arm will be provided food to induce a state of nutritional ketosis in each person as defined as blood [3-OHB] ≥0.5 mM. Receives: Other: Nutritional and Dietary Manipulation |
| Low-fat mixed Diet | Experimental | This arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%). Receives: Other: Nutritional and Dietary Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maximal exercise performance
Participants will undergo VO2 max testing, conducted by trained professionals. VO2 max testing analyses will determine changes in maximal exercise performance
Measured: Baseline and end of study participation, 6 weeks
Secondary outcomes (4)
Change in CMR measures of cardiac function
Participants will undergo MRI scans, conducted by trained professionals. MRI imaging analyses will determine cardiac function. The images will be analyzed by trained imaging professionals to determine overall change in cardiac function.
Measured: Baseline and end of study participation, 6 weeks
Change in NYHA class
NYHA class will be determined by clinical examination by a qualified cardiovascular physician
Measured: Baseline and end of study participation, 6 weeks
Change in Quality of Life Questionnaire
Participants will complete a quality of life questionnaire several times throughout the study. The questions are divided into three areas: Dyspnea, Fatigue and Emotional Function. The scores for each area are added up and divided by the number of questions. A 7-point scale is used for all areas where 1 is the best and 7 is the worst.
Measured: Baseline and end of study participation, 6 weeks
Change in Serologic Markers
Cardio-metabolic risk markers will be determined through blood samples taken throughout the study. We will look at B-natriuretic peptide (BNP), total cholesterol, HDL, LDL, triglycerides, lipoprotein particle distribution, fasting blood glucose, serum potassium, sodium, and magnesium.
Measured: Baseline and end of study participation, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start22 Dec 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Study stopped recruiting during the pandemic and then PI left OSU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sitaramesh Emani, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235699
- Sponsor's protocol ID
- 2019H0255
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2020
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final results will be published via peer-review process.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Ketogenic Diet in Patients With Heart Failure With Preserved Ejection Fraction: A Pilot Study
- ClinicalTrials.gov ID
- NCT04235699
- Acronym / sponsor ID
- 2019H0255
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped recruiting during the pandemic and then PI left OSU.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jan 2020 (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 is being done to evaluate the effects of a low carbohydrate ketogenic diet on exercise tolerance in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), also known as Diastolic Heart Failure (DHF).
Detailed description
Patients will be randomized to either a ketogenic diet, or a low-fat diet higher in carbohydrate and based on current dietary guidelines. Regardless of what group you are randomized to, you will consume the diet for a period of 4 weeks. All foods will be prepared by our research group and provided to you. Both diets will be based on an approximately 25% reduction in your dietary caloric requirements, so some weight loss may occur over the 4-week intervention.
Primary data collection will occur at baseline and at four weeks, with more frequent monitoring of blood markers, blood pressure, heart rate, and overall health. Throughout the duration of the study, you will be continued on standard heart failure therapies as guided by your treating physician. The duration of the study is expected to last for approximately 6 weeks. This includes all before and after testing, as well as the 4 weeks on diet.
All patients will undergo a resting MRI scan of the heart at enrollment (baseline), and again at the end of the 4-week diet. You will not receive any injections.
All participants will also undergo a cardiopulmonary stress test (CPET, also known as VO2 testing) at enrollment (baseline) and again at the end of the 4-week dietary intervention. During the Cardiopulmonary stress testing you will be asked to exercise on a treadmill while breathing into a mask.
All participants will also undergo body fat and body fluid composition by dual-energy X-ray absorptiometry (DXA) at enrollment (baseline) and again at the end of the 4 week dietary intervention. You will be exposed to a very small amount of radiation by the DXA scanner used to measure your body composition. However, amount of radiation used in DXA is extremely low (by comparison, a standard chest x-ray is 125 times more radiation than a DXA scan).
Blood tests will be performed at enrollment (baseline) and again at the end of the 4 week dietary intervention. Blood draws may cause discomfort at the skin puncture site and a small bruise may develop that may persist for several weeks. There is also a small possibility of an infection. These risks are identical to standard clinical blood draws.
After 2-weeks, and again after 4 weeks on diet, all participants will undergo a clinical examination by a cardiologist.
All participants will be provided with a handheld glucometer and test strips to check ketone levels daily in the morning after an overnight fast. This requires a finger prick to obtain the drop of blood required for the test. The finger stick may cause a slight immediate discomfort at the specific stick site. Subjects will also be required to check and record ketones 4x/day on one day per week to capture a more accurate record of ketone levels during waking hours. You will bring the glucometer readings with you when you pick up food so that the results can be downloaded and recorded by a member of the research team.
Patients on either diet will personally pick up food 3X per week. Patients will weigh-in and have their heart rate and blood pressure checked at the time of each food pick up. The MRI, the cardiopulmonary stress test and all blood testing will be done at the Ross Heart Hospital or the Davis Heart and Lung Research Institute. The DXA testing, as well as the food pickup will be done at the Physical Activity and Educational Services (PAES) building on The Ohio State University campus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Nutritional and Dietary ManipulationThis arm will be provided food to induce a state of nutritional ketosis in each person as defined as blood [3-OHB] ≥0.5 mM. |
| Low-fat mixed Diet | Experimental | Other: Nutritional and Dietary ManipulationThis arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old and ≤ 75 years old \& willingness to be randomized to either diet
- Confirmed diagnosis of heart failure with ejection fraction ≥50% (NYHA Class II-IV)
- On optimal medical therapy for at least 3 months as determined by the treating physician
- Body Mass Index (BMI) ≥ 25
- Ability to participate in exercise treadmill testing
Key exclusion criteria (14 listed)
- Contraindications to MRI including pregnancy
- Diagnosis of diabetes mellitus treated with insulin or SGLT2 inhibitors.
- History of diabetic ketoacidosis
- Recent (within 30 days) or planned (within 30 days) cardiac revascularization
- Recent acute myocardial infarction or acute coronary syndrome (30 days)
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 |
|---|---|---|
| Nutritional and Dietary ManipulationParticipants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects. | Other | Ketogenic Diet, Low-fat mixed Diet |
Primary outcome
Changes in maximal exercise performance
Time frame: Baseline and end of study participation, 6 weeks
Participants will undergo VO2 max testing, conducted by trained professionals. VO2 max testing analyses will determine changes in maximal exercise performance
4 secondary outcomes
Change in CMR measures of cardiac function
Time frame: Baseline and end of study participation, 6 weeks
Change in NYHA class
Time frame: Baseline and end of study participation, 6 weeks
Change in Quality of Life Questionnaire
Time frame: Baseline and end of study participation, 6 weeks
Change in Serologic Markers
Time frame: Baseline and end of study participation, 6 weeks
Results and safety
The study was stopped early (reason given: Study stopped recruiting during the pandemic and then PI left OSU.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Yes. Final results will be published via peer-review process.
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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.
Sitaramesh Emani, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and Dietary Manipulation in people with Heart Failure With Preserved Ejection Fraction, run by Ohio State University at 1 site in United States.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Study stopped recruiting during the pandemic and then PI left OSU.). Results are not available in the source record.
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?
Changes in maximal exercise performance (time frame: Baseline and end of study participation, 6 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 24 Jul 2024.