NCT05757193CompletedPhase 1
Ketone Pharmacokinetic Study in HFrEF
Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Feb 2023
- Start date
- 2 Jun 2023
- Primary completion date
- 11 Jan 2024
- Lead sponsor
- Duke University
- Diseases
- Heart failure
- NCT number
- NCT05757193
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 2 Jun 2023 to the primary completion date, 11 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for \>7 days prior to visit)
Other illness
- 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.
- Type 1 diabetes mellitus
- Use of ventricular assist device, history of heart transplant, or use of continuous inotropes
Age
- 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.
Other
- Estimated glomerular filtration rate\<25 mL/min/1.73 m2 as the most recent value in the last year.
Who the study is looking for
- Diagnosis of HFrEF (ejection fraction\<=45%)
- Systolic blood pressure greater \>=90 mmHg
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.