Ketogenic Diet in Patients With Heart Failure

NCT04235699 | Terminated DMC

• 1 other identifier: 2019H0255
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and end of study participation, 6 weeks

Secondary Outcomes (4)

• Change in CMR measures of cardiac function

  Baseline and end of study participation, 6 weeks

• Change in NYHA class

  Baseline and end of study participation, 6 weeks

• Change in Quality of Life Questionnaire

  Baseline and end of study participation, 6 weeks

• Change in Serologic Markers

  Baseline and end of study participation, 6 weeks

Study Arms (2)

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.

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%).

Other: Nutritional and Dietary Manipulation

Interventions

Nutritional and Dietary Manipulation OTHER

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.

Ketogenic Diet; Low-fat mixed Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Study Officials

• Sitaramesh Emani, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 22, 2020
• Study Start: December 22, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)