Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL161348-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketone ester | Experimental | (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester |
|
| placebo | Placebo Comparator | KE-free solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketone ester | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal exercise capacity | Peak VO2 assessed by cardiopulmonary exercise testing | 60 minutes after the intervention |
| Submaximal exercise capacity | Exercise time at 75% of peak workload assessed by cardiopulmonary exercise testing | 30 minutes after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular systolic function | Left ventricular ejection fraction measured during resting echocardiography. | Assessed 30 minutes after the intervention |
| Substrate utilization | Substrate utilization (reflected by the respiratory exchange ratio) assessed by cardiopulmonary exercise testing. |
| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular function | Right ventricular function (tricuspid annular planar systolic excursion) assessed by echocardiography at rest | Assessed 30 minutes after the intervention |
| Cardiac output | Cardiac output measured during stress echocardiography |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Senthil Selvaraj, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007662 | Ketosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
Not provided
Not provided
| ID | Term |
|---|---|
| C524675 | formic acid 4-(3-oxobutyl)phenyl ester |
Not provided
Not provided
Not provided
Overview: The overall study design will be a randomized, double-blind crossover comparison of ketone ester (KE) therapy vs. KE-free vehicle in 25 patients with established HF with reduced ejection fraction (HFrEF). The main outcomes will be measures of exercise performance (peak and submaximal exercise).
Not provided
Not provided
Not provided
|
| placebo | Dietary Supplement | 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 |
|
| 60 minutes after the intervention |
| Left ventricular filling pressures | E/e' ratio measured during stress echocardiography | 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) | 60 minutes after the intervention |
| Assessed 60 minutes after the intervention |
| Vasodilation during exercise | Total peripheral resistance measured during cardiopulmonary exercise testing | 60 minutes after the intervention |
| Pulse wave velocity | Pulse wave velocity measured by arterial tonometry | Assessed 50 minutes after the intervention |
| VO2 efficiency | VO2 efficiency (total work performed over oxygen consumed) during submaximal cardiopulmonary exercise testing | Assessed 30 minutes after the intervention |
| Arterial stiffness | Central augmentation index measured during arterial tonometry | Assessed 50 minutes after the intervention |
| Anaerobic threshold | Anaerobic threshold measured during cardiopulmonary exercise testing | Assessed 60 minutes after the intervention |
| Pulmonary artery pressure | Pulmonary artery systolic pressure assessed through echocardiography during cardiopulmonary exercise testing | Assessed 60 minutes after the intervention |
| Ventilatory efficiency | Ratio of minute ventilation to carbon dioxide production measured during cardiopulmonary exercise testing | Assessed 60 minutes after the intervention |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |