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Ketogenic Diet in Patients With Heart Failure

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional and Dietary Manipulation
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ketogenic Diet

Low-fat mixed Diet

Arm Description

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.

This arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Change in NYHA class
NYHA class will be determined by clinical examination by a qualified cardiovascular physician
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.
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.

Full Information

First Posted
January 15, 2020
Last Updated
October 10, 2022
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04235699
Brief Title
Ketogenic Diet in Patients With Heart Failure
Official Title
Benefits of Ketogenic Diet in Patients With Heart Failure With Preserved Ejection Fraction: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-fat mixed Diet
Arm Type
Experimental
Arm Description
This arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%).
Intervention Type
Other
Intervention Name(s)
Nutritional and Dietary Manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in maximal exercise performance
Description
Participants will undergo VO2 max testing, conducted by trained professionals. VO2 max testing analyses will determine changes in maximal exercise performance
Time Frame
Baseline and end of study participation, 6 weeks
Secondary Outcome Measure Information:
Title
Change in CMR measures of cardiac function
Description
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.
Time Frame
Baseline and end of study participation, 6 weeks
Title
Change in NYHA class
Description
NYHA class will be determined by clinical examination by a qualified cardiovascular physician
Time Frame
Baseline and end of study participation, 6 weeks
Title
Change in Quality of Life Questionnaire
Description
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.
Time Frame
Baseline and end of study participation, 6 weeks
Title
Change in Serologic Markers
Description
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.
Time Frame
Baseline and end of study participation, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debbie Scandling, BS
Phone
614-688-5623
Email
debbie.scandling@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Richard LaFountain, PhD
Phone
614-688-4760
Email
lafountain.9@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sitaramesh Emani, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Scandling
Phone
614-688-5623
Email
debbie.scandling@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final results will be published via peer-review process.

Learn more about this trial

Ketogenic Diet in Patients With Heart Failure

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