Status:
UNKNOWN
Nutritional Ketosis in Heart Failure
Lead Sponsor:
Thomas Jefferson University
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Chronic, ambulatory heart failure patients will be given ketone ester dietary supplementation to determine therapeutic efficacy, metabolic adaptation, pharmacokinetics, associated cognitive changes, a...
Detailed Description
We previously demonstrated a metabolic signature of increased ketone utilization-increased peripheral blood concentration of beta-hydroxybutyrate (BHB) and decreased myocardial concentration of BHB-an...
Eligibility Criteria
Inclusion
- Equal to or greater than 18 years of age
- Diagnosis of heart failure and be classified as NYHA Class II or III either pre-enrollment or at the time of enrollment
- Stable medical therapy for at least 1 month prior to enrollment
- Taking appropriate daily cardiac medications as determined by the principal investigator, who is a heart failure specialist
Exclusion
- Atrial fibrillation
- Inability to exercise on a supine bicycle.
- Moderate or greater valvular disease.
- Hemoglobin \<10 g/dL.
- Daily insulin use
- Hypertrophic, infiltrative, or inflammatory cardiomyopathy.
- Pericardial disease.
- Current angina due to clinically significant obstructive epicardial coronary disease
- Acute coronary syndrome or coronary intervention within the past 2 months.
- Primary pulmonary arteriopathy.
- Known clinically significant lung disease defined as:
- Current use of supplemental oxygen, aside from nocturnal O2 for the treatment of obstructive sleep apnea
- The use of steroids/antibiotics within the past 6 months for an acute exacerbation of obstructive pulmonary disease
- 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)
- Most proximal 6-minute walk test during which the subject experienced arterial desaturation (\<94%) without a subsequent normal study.
- Ischemia on stress testing without subsequent revascularization or left heart catheterization showing non-obstructive epicardial coronary disease.
- Significant liver disease impacting synthetic function or volume control.
- Uncontrolled hypertension: BP \>180/110 at baseline.
- eGFR \<30 mL/min/m2 or Cr \>2.5.
- Alcohol dependence
- Chronic narcotic use that cannot be interrupted
- Pregnant or lactating females
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04370600
Start Date
June 1 2020
End Date
June 1 2021
Last Update
May 1 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.