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Ketogenic Diet in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235699
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Sitaramesh Emani, Ohio State University

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).

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Other: Nutritional and Dietary Manipulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benefits of Ketogenic Diet in Patients With Heart Failure With Preserved Ejection Fraction: A Pilot Study
Actual Study Start Date : December 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Ketogenic Diet
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.
Other: Nutritional and Dietary Manipulation
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.

Experimental: Low-fat mixed Diet
This arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%).
Other: Nutritional and Dietary Manipulation
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in CMR measures of cardiac function [ Time Frame: Baseline and end of study participation, 6 weeks ]
    Participants will undergo MRI scans, conducted by trained professionals. MRI imaging analyses will determine cardiac function

  2. Change in NYHA class [ Time Frame: Baseline and end of study participation, 6 weeks ]
    NYHA class will be determined by clinical examination by a qualified cardiovascular physician

  3. Change in Quality of Life Questionnaire [ Time Frame: Baseline and end of study participation, 6 weeks ]
    Participants will complete a quality of life questionnaire several times throughout the study

  4. Change in Serologic Markers [ Time Frame: Baseline and end of study participation, 6 weeks ]
    cardio-metabolic risk markers will be determined through blood samples taken throughout the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 and ≤ 40
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235699


Contacts
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Contact: Debbie Scandling, BS 614-688-5623 debbie.scandling@osumc.edu
Contact: Richard LaFountain, PhD 614-688-4760 lafountain.9@osu.edu

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Debbie Scandling    614-688-5623    debbie.scandling@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Sitaramesh Emani, MD The Ohio State University Wexner Medical Center

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Responsible Party: Sitaramesh Emani, Associate Professor-Clinical, Cardiovascular Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT04235699    
Other Study ID Numbers: 2019H0255
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final results will be published via peer-review process.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases