A Phase 2 interventional study of ketone ester and placebo in Heart Failure With Reduced Ejection Fraction, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
Among 64 studies in Heart Failure by Duke University — 7 open to participants now, 7 under way, none of them phase 3. Heart Failure · Duke University.
Among the 64 studies in Heart Failure by Duke University, this one is the 43rd largest by enrollment of the 58 interventional ones that give a count, is one of 2 that started in 2024, is one of 9 in phase 2, and was the 58th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →7 of the 64 studies in Heart Failure by Duke University are open now, in 2 countries. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 18+
Duke University · Sites in United States, Canada
Ages 0–20 · Healthy volunteers
Duke University · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
64 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 9 · Phase 4 4
First in 2002; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 152 across the 58 interventional studies, 126 across the 6 observational. Of the 53 that completed or were terminated, 25 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
4 of the studies in Heart Failure by Duke University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT05879211Duke UniversityGoal Concordant Care Learning Laboratory | 2026-12 |
| NCT07101289Duke UniversityEat Well Heart Failure | 2026-12 |
| NCT06937320Duke UniversityChronic Exogenous Ketosis in HFpEF | 2027-06 |
Among the 64 studies in Heart Failure by Duke University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to understand the effects of a ketone drink on exercise capacity and other cardiovascular parameters in patients with heart failure. In heart failure, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur. This study is assessing whether the ketone drink can improve these symptoms. This drink has been given status by Food and Drug Administration as "generally regarded as safe".
The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester
Dietary Supplement: ketone ester
KE-free solution
Dietary Supplement: placebo
500 mg/kg of ketone ester administered approximately 1 hour prior to the maximal exercise testing and 250 mg/kg administered approximately 30 minutes prior to submaximal exercise testing
Also known as: ketone drink, KE drink, KE therapy, DeltaG therapy, ketone therapy
ketone-free placebo administered approximately 1 hour prior to the maximal exercise testing and ketone-free placebo administered approximately 30 minutes prior to submaximal exercise testing
Maximal exercise capacity
Peak VO2 assessed by cardiopulmonary exercise testing
Time frame: 60 minutes after the intervention
Submaximal exercise capacity
Exercise time at 75% of peak workload assessed by cardiopulmonary exercise testing
Time frame: 30 minutes after the intervention
Left ventricular systolic function
Left ventricular ejection fraction measured during resting echocardiography.
Time frame: Assessed 30 minutes after the intervention
Substrate utilization
Substrate utilization (reflected by the respiratory exchange ratio) assessed by cardiopulmonary exercise testing.
Time frame: 60 minutes after the intervention
Left ventricular filling pressures
E/e' ratio measured during stress echocardiography
Time frame: Assessed 60 minutes after the intervention
Vasodilation at rest
Total peripheral resistance measured at rest (calculated using cardiac output from echocardiography and brachial blood pressure)
Time frame: 60 minutes after the intervention
Right ventricular function
Right ventricular function (tricuspid annular planar systolic excursion) assessed by echocardiography at rest
Time frame: Assessed 30 minutes after the intervention
Cardiac output
Cardiac output measured during stress echocardiography
Time frame: Assessed 60 minutes after the intervention
Vasodilation during exercise
Total peripheral resistance measured during cardiopulmonary exercise testing
Time frame: 60 minutes after the intervention
Pulse wave velocity
Pulse wave velocity measured by arterial tonometry
Time frame: Assessed 50 minutes after the intervention
VO2 efficiency
VO2 efficiency (total work performed over oxygen consumed) during submaximal cardiopulmonary exercise testing
Time frame: Assessed 30 minutes after the intervention
Arterial stiffness
Central augmentation index measured during arterial tonometry
Time frame: Assessed 50 minutes after the intervention
Anaerobic threshold
Anaerobic threshold measured during cardiopulmonary exercise testing
Time frame: Assessed 60 minutes after the intervention
Pulmonary artery pressure
Pulmonary artery systolic pressure assessed through echocardiography during cardiopulmonary exercise testing
Time frame: Assessed 60 minutes after the intervention
Ventilatory efficiency
Ratio of minute ventilation to carbon dioxide production measured during cardiopulmonary exercise testing
Time frame: Assessed 60 minutes after the intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2024 to primary completion in Aug 2026, 29 months.
Of 111 non-industry phase 2 interventional studies under Heart Failure, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 66. This study's 29 months is below that.
Counting every sponsor, half of 184 studies reached it within 29 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beta-hydroxybutyrate-1,3-butanediol monoester