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Ketogenic Diet for Heart Failure
N/A
Recruiting
Led By Sitaramesh Emani, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of heart failure with ejection fraction ≥50% (NYHA Class II-IV)
Age ≥ 18 years old and ≤ 75 years old & willingness to be randomized to either diet
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of study participation, 6 weeks
Awards & highlights
Study Summary
This trial is studying how well a low-carbohydrate ketogenic diet works in improving exercise tolerance in patients with HFpEF.
Who is the study for?
This trial is for adults aged 18-75 with heart failure where the heart's lower chambers are still pumping well (HFpEF), who have a BMI of 25 or more but not over 40, and have been on stable heart medication for at least three months. It excludes those with severe liver disease, high metformin use, recent major heart procedures, untreated sleep apnea, certain diabetes treatments or complications, very weak hearts, serious lung conditions, uncontrolled high blood pressure, significant valve disease in the heart or dangerous irregular heartbeat history.Check my eligibility
What is being tested?
The study tests if a low-carb ketogenic diet can improve exercise ability in patients with HFpEF. Participants will be randomly assigned to follow this special diet and their exercise performance will be measured using treadmill testing.See study design
What are the potential side effects?
Potential side effects from following a ketogenic diet may include fatigue during initial adjustment ('keto flu'), constipation due to lack of fiber intake, possible nutrient deficiencies without proper planning and supplementation as needed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is normal or near normal, but I have heart failure symptoms.
Select...
I am between 18 and 75 years old and open to trying a new diet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and end of study participation, 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of study participation, 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in maximal exercise performance
Secondary outcome measures
Change in CMR measures of cardiac function
Change in NYHA class
Change in Quality of Life Questionnaire
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Low-fat mixed DietExperimental Treatment1 Intervention
This arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%).
Group II: Ketogenic DietExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,611 Total Patients Enrolled
17 Trials studying Heart Failure
52,865 Patients Enrolled for Heart Failure
Sitaramesh Emani, MDPrincipal Investigator - The Ohio State University Wexner Medical Center
OSU Harding Hospital, Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital
Ohio State University College Of Medicine (Medical School)
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Heart Failure
10 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or severe heart issue in the last 30 days.I take more than 1700 mg of metformin daily.My heart's pumping ability is normal or near normal, but I have heart failure symptoms.Your heart's pumping ability is less than 50%.I have been diagnosed with liver cirrhosis.I have diabetes and am treated with insulin or SGLT2 inhibitors.I have had diabetic ketoacidosis in the past.I have had or will have a procedure to improve blood flow to my heart within a month.You have a heart condition that affects your heart valves and it is detected with an echocardiogram.You weigh more than what is considered healthy for your height.I have been diagnosed with moderate to severe COPD.I have moderate to severe sleep apnea that hasn't been treated.I have had episodes of very fast heartbeats or sudden cardiac arrest.My blood pressure is not higher than 150/90 mmHg.Your body mass index (BMI) is either too low (less than 25) or too high (more than 40).I am between 18 and 75 years old and open to trying a new diet.I have been on the best treatment plan for my condition for at least 3 months.You should not have an MRI if you are pregnant.You are able to take part in treadmill exercises.
Research Study Groups:
This trial has the following groups:- Group 1: Ketogenic Diet
- Group 2: Low-fat mixed Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are subjects over the age of 35 able to participate in this research?
"The minimum age an individual can be to enroll in this trial is 18, with the maximum age being 75."
Answered by AI
For whom is this research program recruiting?
"This study is for heart failure patients within the age range of 18 to 75. Up to 24 patients are needed for the clinical trial."
Answered by AI
How many total participants are being allowed in this experiment?
"The clinicaltrials.gov website indicates that this study is actively recruiting patients. The trial was posted on December 22, 2019 and was last updated on October 10, 2020. The study is enrolling 24 participants at a single location."
Answered by AI
If a patient meets the qualifications, can they join the trial at this time?
"The most recent information from clinicaltrials.gov suggests that this study is still recruiting patients. This research was first made public on December 22nd, 2019 and was edited most recently on October 10th, 2022."
Answered by AI
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