A Phase 1 interventional study of Digoxin and Placebo in Inflammatory Response, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Yale University · Phase 1, Interventional, and Basic science
To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.
To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.
To investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.
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Exclusion criteria
Patients receiving oral digoxin 3 mcg/Kg/day
Drug: Digoxin
Patients receiving oral digoxin 0.15 mcg/Kg/day
Drug: Digoxin
oral placebo
Other: Placebo
Participants will receive 3 mcg/Kg/day doses of oral digoxin
Oral placebo
Participants will receive 0.15 mcg/Kg/day doses of oral digoxin
Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
Time frame: after starting digoxin
Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
Time frame: 1 week after starting digoxin
Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
Time frame: 2 weeks after starting digoxin
Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
Time frame: 3 weeks after starting digoxin
Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro
Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations.
Time frame: 6 weeks
| Milestone | Digoxin 3 mcg/Kg/Day | Digoxin 0.15 mcg | Placebo |
|---|---|---|---|
| Started | 14 | 14 | 14 |
| Completed | 6 | 6 | 7 |
| Not completed | 8 | 8 | 7 |
Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
No measurements were reported for this outcome.
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
No measurements were reported for this outcome.
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
No measurements were reported for this outcome.
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
No measurements were reported for this outcome.
Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations.
| pg/ml | Digoxin 3 mcg/Kg/Day | Digoxin 0.15 mcg | Placebo |
|---|---|---|---|
| CCL2 | 697 ± 237 | 1351 ± 483 | 5790 ± 2442 |
| CCL4 | 1205 ± 569 | 12180 ± 9763 | 22328 ± 7251 |
| CCL20 | 894 ± 490 | 1205 ± 569 | 1761 ± 471 |
| CXCL1 | 312 ± 232 | 1437 ± 340 | 2909 ± 725 |
| CXCL10 | 366 ± 293 | 2472 ± 886 | 4452 ± 1549 |
| G-CSF | 35 ± 19 | 211 ± 80 | 323 ± 129 |
| GM-CSF | 42 ± 15 | 142 ± 39 | 231 ± 60 |
| Granzyme B | 182 ± 60 | 1117 ± 684 | 2734 ± 1582 |
| IFN Alpha | 26 ± 31 | 97 ± 61 | 174 ± 109 |
| IFN Gamma | 27 ± 9 | 103 ± 82 | 229 ± 99 |
| IL-RA | 1074 ± 290 | 6040 ± 1785 | 12618 ± 3485 |
| IL-6 | 1064 ± 427 | 2797 ± 831 | 5006 ± 1171 |
| PDGF AA | 238 ± 294 | 1519 ± 773 | 2848 ± 135 |
| PDGF AB/BB | 128 ± 75 | 908 ± 539 | 1038 ± 587 |
| TNF Alpha | 173 ± 92 | 2786 ± 956 | 4040 ± 1004 |
| IL-8 | 117 ± 41 | 306 ± 52 | 420 ± 24 |
| Galactin 9 | 11977 ± 4287 | 20623 ± 5876 | 25999 ± 2645 |
| IL10 | 26069 ± 6793 | 17528 ± 9660 | 2300 ± 2230 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digoxin 3 mcg/Kg/Day | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Digoxin 0.15 mcg | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Placebo | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
Baseline characteristics were only collected from completers.
| Age, Continuous(years) | Digoxin 3 mcg/Kg/Day | Digoxin 0.15 mcg | Placebo | Total |
|---|---|---|---|---|
| Mean | 39.1 ± 9 | 31.3 ± 15 | 37.7 ± 12 | 36.1 ± 12 |
| Sex: Female, Male(Participants) | Digoxin 3 mcg/Kg/Day | Digoxin 0.15 mcg | Placebo | Total |
|---|---|---|---|---|
| Female | 5 | 5 | 4 | 14 |
| Male | 1 | 1 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Digoxin 3 mcg/Kg/Day | Digoxin 0.15 mcg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 3 | 3 |
| White | 4 | 6 | 1 | 11 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 1 | 3 |
| Region of Enrollment(participants) | Digoxin 3 mcg/Kg/Day | Digoxin 0.15 mcg | Placebo | Total |
|---|---|---|---|---|
| United States | 6 | 6 | 7 | 19 |
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Yale University