Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT05757193
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of HFrEF (ejection fraction\<=45%)
* Systolic blood pressure greater \>=90 mmHg
Exclusion Criteria:
* Intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for \>7 days prior to visit)
* Significant liver disease (cirrhosis) or alcohol abuse disorder (\>14 drinks/week).
* Unique cardiomyopathies: infiltrative/hypertrophic cardiomyopathy, pericardial disease, or other cardiomyopathies that in the investigator's opinion have unique treatment options that would be less likely to be affected by ketone therapy.
* Estimated glomerular filtration rate\<25 mL/min/1.73 m2 as the most recent value in the last year.
* Type 1 diabetes mellitus
* Use of ventricular assist device, history of heart transplant, or use of continuous inotropes
* Pregnant women. Due to unknown affects of nutritional ketosis in pregnant women, pregnancy will be an exclusion. Accordingly, women of childbearing age with a menstrual cycle within the past year will be asked to submit a urine specimen for pregnancy testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05757193
Study Brief:
Protocol Section:
NCT05757193