Nutritional Ketosis in Heart Failure

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic, ambulatory heart failure patients will be given ketone ester dietary supplementation to determine therapeutic efficacy, metabolic adaptation, pharmacokinetics, associated cognitive changes, and safety within this patient cohort in order to establish preliminary data to later conduct a multi-center randomized clinical trial.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University

Criteria

Inclusion Criteria:

1. Equal to or greater than 18 years of age

2. Diagnosis of heart failure and be classified as NYHA Class II or III either pre-enrollment or at the time of enrollment

3. Stable medical therapy for at least 1 month prior to enrollment

4. Taking appropriate daily cardiac medications as determined by the principal investigator, who is a heart failure specialist

Exclusion Criteria:

1. Atrial fibrillation

2. Inability to exercise on a supine bicycle.

3. Moderate or greater valvular disease.

4. Hemoglobin <10 g/dL.

5. Daily insulin use

6. Hypertrophic, infiltrative, or inflammatory cardiomyopathy.

7. Pericardial disease.

8. Current angina due to clinically significant obstructive epicardial coronary disease

9. Acute coronary syndrome or coronary intervention within the past 2 months.

10. Primary pulmonary arteriopathy.

11. Known clinically significant lung disease defined as:

1. Current use of supplemental oxygen, aside from nocturnal O2 for the treatment of obstructive sleep apnea

2. The use of steroids/antibiotics within the past 6 months for an acute exacerbation of obstructive pulmonary disease

3. Most proximal pulmonary function test indicating severe obstructive disease, defined as an FEV1<50% predicted in the context of an FEV1/FVC ratio of <0.70 ("Stage III COPD according to GOLD Criteria). (note: only to be used if the subject had PFTs prior to screening)

4. Most proximal 6-minute walk test during which the subject experienced arterial desaturation (<94%) without a subsequent normal study.

12. Ischemia on stress testing without subsequent revascularization or left heart catheterization showing non-obstructive epicardial coronary disease.

13. Significant liver disease impacting synthetic function or volume control.

14. Uncontrolled hypertension: BP >180/110 at baseline.

15. eGFR <30 mL/min/m2 or Cr >2.5.

16. Alcohol dependence

17. Chronic narcotic use that cannot be interrupted

18. Pregnant or lactating females